Synopsis
0
VMF
0
Canada
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Click Us!
JDMF
KDMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC
Jai Radhe Sales is your partner for all your sourcing needs.
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-12
Pay. Date : 2016-06-21
DMF Number : 25638
Submission : 2011-12-29
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20494
Submission : 2007-04-30
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Ibandronate Sodium Monohydrate, Type I
Certificate Number : R0-CEP 2023-077 - Rev 00
Status : Valid
Issue Date : 2023-06-30
Type : Chemical
Substance Number : 2771
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Ibandronate Sodium Monohydrate
Certificate Number : R0-CEP 2022-073 - Rev 00
Status : Valid
Issue Date : 2023-02-20
Type : Chemical
Substance Number : 2771
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Ibandronate Sodium Monohydrate
Registration Number : 303MF10116
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2021-07-20
Latest Date of Registration : 2021-07-20
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Ibandronate Sodium Form Beta IH/Ibandronate Sodium Monohydrate IH
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2013-01-21
Registration Number : Number 2417-3-ND
Manufacturer Name : Pharmaceutical Works Polphar...
Manufacturer Address : 19, Pelplinska Str. 83-200 Starogard Gdanski, Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2019-08-02
Registration Number : No. 2417-3-ND(1)
Manufacturer Name : Pharmaceutical Works Polphar...
Manufacturer Address : 19. Pelplinska Str, 83-200 Starogard Gdanski, Poland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Ibandronat Zentiva Osteo
Dosage Form : Inj L?s
Dosage Strength : 3mg/3ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : IBANDRONIC ACID THINK
Dosage Form : Film-Coated Tablets
Dosage Strength : 150 mg
Packaging : 1 UNIT 150 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21455
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21455
DOSAGE - INJECTABLE;INTRAVENOUS - EQ 3MG BASE...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21858
Related Excipient Companies
Minakem
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Dosage Form : Capsule
Grade : Oral
Brand Name : Sodium Stearyl Fumarate G...
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.
Pharmacopoeia Ref : USP, EP, ICH, Q7GMP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Chynops Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pramukh Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NEWEDGE Overseas
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
Brand Name : Sodium Stearyl Fumarate
Application : Lubricants & Glidants
Excipient Details : Sodium stearyl fumarate is used as a lubricant to reduce friction and adhesion in pharmaceutical solid oral formulations such as tablets and capsules.
Pharmacopoeia Ref : IH/BP/USP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate Excipient
Delivering high-quality, innovative solutions with regulatory excellence for the healthcare and chemical industries worldwide.
Brand Name : Sodium Stearyl Fumarate
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength and disintegration.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX AV01PhG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.
Fillers, Diluents & Binders
Controlled & Modified Release
Lubricants & Glidants
Thickeners and Stabilizers
Film Formers & Plasticizers
Disintegrants & Superdisintegrants
Granulation
Direct Compression
Topical
Solubilizers
Parenteral
Co-Processed Excipients
Taste Masking
Chewable & Orodispersible Aids
Rheology Modifiers
Empty Capsules
API Stability Enhancers
Coloring Agents
Emulsifying Agents
Vegetarian Capsules
Soft Gelatin
Surfactant & Foaming Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Regulatory FDF Prices
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class B
Dosage Form : Inj L?s
Dosage Strength : 3mg/3ml
Price Per Pack (Euro) : 44.11
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
RX/OTC/DISCN :
Dosage Form : Film-Coated Tablets
Dosage Strength : 150 mg
Price Per Pack (Euro) : 13
Published in :
Country : Italy
RX/OTC/DISCN :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
55
PharmaCompass offers a list of Ibandronate Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ibandronate Sodium manufacturer or Ibandronate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ibandronate Sodium manufacturer or Ibandronate Sodium supplier.
PharmaCompass also assists you with knowing the Ibandronate Sodium API Price utilized in the formulation of products. Ibandronate Sodium API Price is not always fixed or binding as the Ibandronate Sodium Price is obtained through a variety of data sources. The Ibandronate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ibandronate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibandronate Sodium, including repackagers and relabelers. The FDA regulates Ibandronate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibandronate Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ibandronate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibandronate Sodium supplier is an individual or a company that provides Ibandronate Sodium active pharmaceutical ingredient (API) or Ibandronate Sodium finished formulations upon request. The Ibandronate Sodium suppliers may include Ibandronate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Ibandronate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ibandronate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibandronate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Ibandronate Sodium DMFs exist exist since differing nations have different regulations, such as Ibandronate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibandronate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Ibandronate Sodium USDMF includes data on Ibandronate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibandronate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibandronate Sodium suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Ibandronate Sodium Drug Master File in Japan (Ibandronate Sodium JDMF) empowers Ibandronate Sodium API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Ibandronate Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Ibandronate Sodium JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Ibandronate Sodium suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ibandronate Sodium Drug Master File in Korea (Ibandronate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ibandronate Sodium. The MFDS reviews the Ibandronate Sodium KDMF as part of the drug registration process and uses the information provided in the Ibandronate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ibandronate Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ibandronate Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ibandronate Sodium suppliers with KDMF on PharmaCompass.
A Ibandronate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Ibandronate Sodium Certificate of Suitability (COS). The purpose of a Ibandronate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ibandronate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ibandronate Sodium to their clients by showing that a Ibandronate Sodium CEP has been issued for it. The manufacturer submits a Ibandronate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ibandronate Sodium CEP holder for the record. Additionally, the data presented in the Ibandronate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ibandronate Sodium DMF.
A Ibandronate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ibandronate Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Ibandronate Sodium suppliers with CEP (COS) on PharmaCompass.
A Ibandronate Sodium written confirmation (Ibandronate Sodium WC) is an official document issued by a regulatory agency to a Ibandronate Sodium manufacturer, verifying that the manufacturing facility of a Ibandronate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ibandronate Sodium APIs or Ibandronate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Ibandronate Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Ibandronate Sodium suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ibandronate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ibandronate Sodium API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Ibandronate Sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Ibandronate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ibandronate Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ibandronate Sodium suppliers with NDC on PharmaCompass.
Ibandronate Sodium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ibandronate Sodium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ibandronate Sodium GMP manufacturer or Ibandronate Sodium GMP API supplier for your needs.
A Ibandronate Sodium CoA (Certificate of Analysis) is a formal document that attests to Ibandronate Sodium's compliance with Ibandronate Sodium specifications and serves as a tool for batch-level quality control.
Ibandronate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Ibandronate Sodium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ibandronate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Ibandronate Sodium EP), Ibandronate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ibandronate Sodium USP).
