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Looking for reference standards & impurity standards for APIs? Find a leading CMO, CDMO offering primary & secondary standards on PharmaCompass.

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API & Drug Product Development
API Development
Impurity / Reference Standard

US Pharmacopeia Pharmaceutical Analytical Impurities

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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01 1US Pharmacopeia

02 1Advinus Therapeutics Ltd

03 1Almelo

04 2Anacipher

05 1Aozeal Certified Standards

06 1Aragen Life Sciences

07 1Bellen Chemistry

08 1Bioindustria L.I.M. Spa

09 1ChemCon GmbH

10 1Chromcore Lifesciences

11 1Cleanchem Laboratories

12 3Clearsynth Labs Limited

13 2Dalton Pharma Services

14 1Diverchim S.A.

15 1Eurofins CDMO

16 1Evotec

17 1GRAM Laboratory Inc

18 1Kekule Pharma

19 1KriSan Biotech

20 3Maithili Life Sciences

21 1Prague Scientific

22 1Priyans Drugs

23 1Recipharm AB

24 1SVAK Life Sciences

25 1Sai Life Sciences Limited

26 1Solara Active Pharma Sciences

27 1TopChem Pharmaceuticals

28 1UQUIFA

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34 All

01 2Canada

02 1China

03 1Czech Republic

04 2France

05 2Germany

06 17India

07 1Ireland

08 1Italy

09 1Singapore

10 1Spain

11 1Sweden

12 1Taiwan

13 3U.S.A

price-trend

01

US Pharmacopeia

USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

Pharma Service : API & Drug Product Development

USP IMPURITY REFERENCE STANDARDS

USP Impurity Reference Standards are built on a foundation of rigorous science and developed based on input from a global independent network of scientific experts knowledgeable in R&D, manufacturing, regulations and healthcare.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

USP Impurity Reference Standards

Service
Web Link

Capabilities
#ServicesBio

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02

Advinus Therapeutics Ltd

METABOLITE AND IMPURITY SYNTHESIS

DIA 2025

Not Confirmed

Advinus Therapeutics Ltd

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

METABOLITE AND IMPURITY SYNTHESIS

Advinus offers a full range of chemistry services spanning miligram scale synthesis for efficacy and toxicology studies, to multi kilogram scale cGMP scale-up for early clinical development.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

03

Maithili Life Sciences

SYNTHESIS & ISOLATION OF IMPURITIES

DIA 2025

Not Confirmed

Maithili Life Sciences

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

SYNTHESIS & ISOLATION OF IMPURITIES

Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

04

UQUIFA

IMPURITY PROFILE CHARACTERIZATION

DIA 2025

Not Confirmed

UQUIFA

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY PROFILE CHARACTERIZATION

Uquifa is a leading company for APIs and advanced intermediates offering capabilities including impurity profile characterization, stability studies, process validation and analytical method development services.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

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05

Bioindustria L.I.M. Spa

DEGRADATION IMPURITIES

DIA 2025

Not Confirmed

Bioindustria L.I.M. Spa

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

DEGRADATION IMPURITIES

Bioindustria L.I.M's R&D laboratories are in charge of synthesizing process and degradation impurities for analytical purposes and to support customers in developing generics.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

06

Solara Active Pharma Sciences

IMPURITY / REFERENCE STANDARD

DIA 2025

Not Confirmed

Solara Active Pharma Sciences

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY / REFERENCE STANDARD

Solara has a synthetic development team dedicated to impurity synthesis, with more than 800 compounds available. Their analytical services include impurity marker & reference standard preparation, qualification, management & distribution.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

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07

Maithili Life Sciences

IMPURITY, DEGRADANT OR METABOLITE ISOLAT...

DIA 2025

Not Confirmed

Maithili Life Sciences

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY, DEGRADANT OR METABOLITE ISOLAT...

Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

08

Clearsynth Labs Limited

RELATED COMPOUNDS & POTENTIAL IMPURITIES

DIA 2025

Not Confirmed

Clearsynth Labs Limited

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

RELATED COMPOUNDS & POTENTIAL IMPURITIES

Clearsynth services are applied at all stages of development. Clearsynth considers all issues related to compounds and potential impurities.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

09

Priyans Drugs

SYNTHESIS OF IMPURITIES & STANDARDS

DIA 2025

Not Confirmed

Priyans Drugs

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

SYNTHESIS OF IMPURITIES & STANDARDS

Priyans Drugs headquartered in Singapore, is a professionally managed company supporting the pharmaceuticals business globally.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

10

Aozeal Certified Standards

SYNTHESIS OF IMPURITIES & REFERENCE STAN...

DIA 2025

Not Confirmed

Aozeal Certified Standards

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

SYNTHESIS OF IMPURITIES & REFERENCE STAN...

Aozeal Certified Standards (AOCS), Inc. is a high-tech biopharmaceutical company specialized in the custom synthesis & supply of API impurities & other pharmaceutical reference standards as per a customers’ desired purity, characterization & quantity.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

11

KriSan Biotech

IMPURITY REFERENCE STANDARDS

DIA 2025

Not Confirmed

KriSan Biotech

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY REFERENCE STANDARDS

KriSan Biotech offers research and process development services to prepare impurity reference standards, active pharmaceutical ingredients (APIs) and intermediates.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

12

Eurofins CDMO

IMPURITY SYNTHESIS

DIA 2025

Not Confirmed

Eurofins CDMO

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

IMPURITY SYNTHESIS

Eurofins CDMO identifies, isolates & synthesizes process related impurities to support process development, analytical control & regulatory requirements. They offer services for the whole drug development process & manage impurities synthesis & control.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

13

Kekule Pharma

IMPURITY SYNTHESIS

DIA 2025

Not Confirmed

Kekule Pharma

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY SYNTHESIS

Kekule Pharma offers various services including impurity synthesis, drug substance contract manufacturing, etc.They specialize in producing products through novel processes taking full advantage of their core competencies, equipment & facilities.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

14

Recipharm AB

REFERENCE STANDARDS

DIA 2025

Not Confirmed

Recipharm AB

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

REFERENCE STANDARDS

Recipharm's specialities include preparation of reference standards & internal standards with stable isotopes, synthesis of complex heterocycles, sugars, steroids, ADC linkers, phosphates, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

15

GRAM Laboratory Inc

API REFERENCE STANDARD QUALIFICATION

DIA 2025

Not Confirmed

GRAM Laboratory Inc

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

API REFERENCE STANDARD QUALIFICATION

GRAM Laboratories provides services geared towards qualification of an active pharmaceutical ingredient, through monograph testing, compendial and vendor method verification, qualification of impurity profile and reference standard qualification.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

16

Maithili Life Sciences

SYNTHESIS OF GMP IMPURITIES

DIA 2025

Not Confirmed

Maithili Life Sciences

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

SYNTHESIS OF GMP IMPURITIES

Maithili undertakes the custom synthesis of key intermediates & active substances (APIs) for innovator companies worldwide. It has expertise in synthesizing diverse classes of molecules & offers gram to ton quantities in a cost-effective manner.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

17

ChemCon GmbH

SYNTHESIS OF REFERENCE STANDARDS

DIA 2025

Not Confirmed

ChemCon GmbH

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

SYNTHESIS OF REFERENCE STANDARDS

ChemCon can synthesize and qualify reference standards as per client's needs. It combines the expertise and facilities of an analytical service provider with those of an experienced custom synthesis development and manufacturing organization (CDMO).

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

18

Anacipher

SYNTHESIS OF KNOWN / UNKNOWN IMPURITIES

DIA 2025

Not Confirmed

Anacipher

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

SYNTHESIS OF KNOWN / UNKNOWN IMPURITIES

With the help of deep organic chemistry knowledge along with state-of-the-art synthesis infrastructure, Anacipher offers synthesis services for known / unknown impurities.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

19

Anacipher

REFERENCE STANDARDS AND IMPURITIES

DIA 2025

Not Confirmed

Anacipher

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

REFERENCE STANDARDS AND IMPURITIES

Reference standards / working standards of impurities & products can be qualified & characterized with a complete report for regulatory submission. Anacipher helps in in-house impurity standard generation by means of degradation & isolation or synthesis.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

20

Clearsynth Labs Limited

REFERENCE STANDARDS

DIA 2025

Not Confirmed

Clearsynth Labs Limited

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

REFERENCE STANDARDS

Clearsynth's team of experienced scientists has expertise in the custom synthesis of a range of small molecules like APIs, chemical intermediates, drug metabolites, drug analogs, analytical standards, reference standards, pharmaceutical impurities, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

21

Clearsynth Labs Limited

PHARMACEUTICAL IMPURITIES

DIA 2025

Not Confirmed

Clearsynth Labs Limited

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

PHARMACEUTICAL IMPURITIES

Clearsynth's team of experienced scientists has expertise in the custom synthesis of a range of small molecules like APIs, chemical intermediates, drug metabolites, drug analogs, analytical standards, reference standards, pharmaceutical impurities, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

22

Prague Scientific

NITROSAMINE IMPURITY SYNTHESIS & ANALYSI...

DIA 2025

Not Confirmed

Prague Scientific

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

NITROSAMINE IMPURITY SYNTHESIS & ANALYSI...

Prague Scientific offers synthesis and analytical characterization of nitrosamine standards with confirmatory nitrosamine testing on the ppb/ppm level (analytical method development and validation).

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

23

Sai Life Sciences Limited

SYNTHESIS OF REFERENCE COMPOUNDS

DIA 2025

Not Confirmed

Sai Life Sciences Limited

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

SYNTHESIS OF REFERENCE COMPOUNDS

The key services offered by Sai Life Sciences include synthesis of reference compounds, lead generation and optimization, preparation of building blocks/key intermediates, metabolites, and impurity markers, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

24

SVAK Life Sciences

IMPURITY REFERENCE STANDARD (IRS)

DIA 2025

Not Confirmed

SVAK Life Sciences

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

IMPURITY REFERENCE STANDARD (IRS)

SVAK handles process development projects, cost reduction projects and impurity standards worldwide for a client base that includes pharmaceuticals, manufacturers of specialty chemicals, as well as universities and various other research institutions.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

25

Cleanchem Laboratories

DEVELOPMENT OF IMPURITY REFERENCE STANDA...

DIA 2025

Not Confirmed

Cleanchem Laboratories

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

DEVELOPMENT OF IMPURITY REFERENCE STANDA...

Cleanchem Laboratories is a contract research and manufacturing service provider that delivers impurity synthesis services. It also offers custom development of impurity reference standards, specialty chemicals, intermediates, metabolites, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

26

TopChem Pharmaceuticals

IMPURITIES, METABOLITES & RELATED MATERI...

DIA 2025

Not Confirmed

TopChem Pharmaceuticals

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITIES, METABOLITES & RELATED MATERI...

Topchem can supply impurity reference standards (IRS), metabolites and related research materials. Using their supply chain network they generally source advanced intermediates to facilitate rapid and cost effective supply of these materials.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

27

Almelo

IMPURITY SYNTHESIS

DIA 2025

Not Confirmed

Almelo

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY SYNTHESIS

The Almelo Research Center (ARC) is a fully established facility for Almelo's in-house and custom product R&D services.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

28

Bellen Chemistry

IMPURITY & REFERENCE STANDARD SYNTHESIS

DIA 2025

Not Confirmed

Bellen Chemistry

DIA 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Pharma Service : API & Drug Product Development

IMPURITY & REFERENCE STANDARD SYNTHESIS

Bellen's development service capabilities include synthesis of reference compounds, impurity markers, preparation of key intermediates, building blocks, design and synthesis of focused libraries, lead optimization and preclinical candidate selection, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

29

Evotec

IMPURITY / REFERENCE STANDARD

DIA 2025

Not Confirmed

Evotec

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY / REFERENCE STANDARD

Evotec supports the key steps of the development of its partner’s APIs in route scouting & identification of a new route, custom synthesis, analytical method development & validation, synthesis of reference standards & impurities, etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

30

Aragen Life Sciences

IMPURITY IDENTIFICATION, CHARACTERISATIO...

DIA 2025

Not Confirmed

Aragen Life Sciences

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY IDENTIFICATION, CHARACTERISATIO...

GVK BIO offers an extensive Process R&D support, designed to address the issues involving both scientific and communication challenges. We are cognizant of the need for customisation as per client’s need.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

31

Chromcore Lifesciences

IMPURITIES TESTING

DIA 2025

Not Confirmed

Chromcore Lifesciences

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITIES TESTING

Chromcore provides various analytical testing services such as impurity testing, dose content uniformity for inhalation products such as dry-powder inhaler (DPI) & metered-dose inhaler (MDI), water or moisture content analysis, drug content (assay), etc.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

32

Dalton Pharma Services

IMPURITY SCREENING

DIA 2025

Not Confirmed

Dalton Pharma Services

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY SCREENING

Identification of Unknown impurities of >0.05% abundance using internally developed or client supplied method.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

33

Diverchim S.A.

IMPURITY REFERENCE STANDARDS (IRS) SUPPL...

DIA 2025

Not Confirmed

Diverchim S.A.

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY REFERENCE STANDARDS (IRS) SUPPL...

DIVERCHIM can supply its customer impurity reference standards, in response to health agencies’ requirements for impurity definition and characterization.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

Digital Content

34

Dalton Pharma Services

IMPURITY REFERENCE STANDARDS

DIA 2025

Not Confirmed

Dalton Pharma Services

DIA 2025

Not Confirmed

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Pharma Service : API & Drug Product Development

IMPURITY REFERENCE STANDARDS

Identified compounds can be ultra-purified for use as reference standards for QC analysis and stability impurity monitoring studies.

Category : API Development

Sub Category : Impurity / Reference Standard

Pharma Service : API & Drug Product Development

Service
Web Link

Capabilities
#ServicesBio

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