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Chemistry

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Also known as: 68278-23-9, Eflornithine hcl, Dfmo, Dl-alpha-difluoromethylornithine hydrochloride, Eflornithinehydrochloride, 2-(difluoromethyl)-dl-ornithine monohydrochloride
Molecular Formula
C6H13ClF2N2O2
Molecular Weight
218.63  g/mol
InChI Key
VKDGNNYJFSHYKD-UHFFFAOYSA-N
FDA UNII
UO07O10TCJ

Eflornithine Hydrochloride
An inhibitor of ornithine decarboxylase, the rate limiting enzyme of the polyamine biosynthetic pathway.
1 2D Structure

Eflornithine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2,5-diamino-2-(difluoromethyl)pentanoic acid;hydrochloride
2.1.2 InChI
InChI=1S/C6H12F2N2O2.ClH/c7-4(8)6(10,5(11)12)2-1-3-9;/h4H,1-3,9-10H2,(H,11,12);1H
2.1.3 InChI Key
VKDGNNYJFSHYKD-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C(CC(C(F)F)(C(=O)O)N)CN.Cl
2.2 Other Identifiers
2.2.1 UNII
UO07O10TCJ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Alpha Difluoromethyl Ornithine

2. Alpha Difluoromethylornithine

3. Alpha-difluoromethyl Ornithine

4. Alpha-difluoromethylornithine

5. Difluoromethylornithine

6. Dl Alpha Difluoromethylornithine

7. Dl-alpha-difluoromethylornithine

8. Eflornithine

9. Eflornithine Monohydrochloride, Monohydrate

10. Mdl 71,782 A

11. Mdl-71,782 A

12. Mdl71,782 A

13. Ornidyl

14. Ornithine, Alpha-difluoromethyl

15. Rmi 71782

16. Vaniqa

2.3.2 Depositor-Supplied Synonyms

1. 68278-23-9

2. Eflornithine Hcl

3. Dfmo

4. Dl-alpha-difluoromethylornithine Hydrochloride

5. Eflornithinehydrochloride

6. 2-(difluoromethyl)-dl-ornithine Monohydrochloride

7. Eflornithine Hydrochloride Anhydrous

8. Dfmo Hcl

9. Eflornithine (hydrochloride)

10. Dfmo Hydrochloride

11. 2,5-diamino-2-(difluoromethyl)pentanoic Acid Hydrochloride

12. Vaniqa

13. Dfmo Hcl;eflornithine Hcl

14. Uo07o10tcj

15. Mls000069341

16. 2,5-diamino-2-(difluoromethyl)pentanoic Acid;hydrochloride

17. D,l-alpha-difluoromethylornithine Hydrochloride

18. Nsc-270295

19. H-alpha-difluoro-me-dl-orn-oh Hcl Ho

20. Ncgc00093850-01

21. Smr000058442

22. .alpha.-dfmo Hcl

23. Dsstox_cid_25765

24. Dsstox_rid_81107

25. Eflornithine . Hcl . Ho;dfmo . Hcl . Ho;alpha-difluoromethylornithine . Hcl . Ho

26. Dsstox_gsid_45765

27. Dfmo;mdl71782;rmi71782;alpha-difluoromethylornithine

28. Dl-ornithine, Monohydrochloride

29. Cas-96020-91-6

30. Ccris 5805

31. Nsc-337250

32. Einecs 269-532-0

33. Unii-uo07o10tcj

34. Sr-01000076229

35. 2-(difluoromethyl)-dl-ornithine Hydrochloride

36. 2-(difluoromethyl)-dl-ornithine Hcl

37. Dl-ornithine, 2-(difluoromethyl)-, Monohydrochloride

38. Nsc 270295

39. Nsc 337250

40. Opera_id_46

41. Eflornithine Hydrocloride

42. Ornithine, 2-(difluoromethyl)-, Monohydrochloride

43. Mls001332583

44. Chembl536971

45. Schembl3022583

46. (rs)-eflornithine Hydrochloride

47. Hy-b0744a

48. Dtxsid601019072

49. L-eflornithine Hydrochloride

50. Bcp11748

51. Dl-alpha-difluoromethylornithine Hcl

52. Tox21_111224

53. Tox21_500429

54. Ac-388

55. Mfcd00274036

56. Nsc270295

57. Akos015895186

58. Tox21_111224_1

59. Ccg-221733

60. Eflornithine Hydrochloride [mi]

61. Ks-1261

62. Lp00429

63. 2-(difluoromethyl)ornithine Hydrochloride

64. Ncgc00015316-05

65. Ncgc00261114-01

66. Dl-

67. A-difluoromethylornithine Hydrochloride

68. E0947

69. Eu-0100429

70. Ft-0630774

71. Dl-2-(difluoromethyl)-ornithine Hydrochloride

72. H-alpha-difluoro-me-dl-orn-oh . Hcl . Ho

73. Dl- Alpha -difluoromethylornithine Hydrochloride

74. 278e239

75. A836071

76. A836749

77. Dl--difluoromethylornithine Hydrochloride Monohydrate

78. Sr-01000076229-1

79. Dl-alpha-difluoromethylornithine Hydrochloride Hydrate

80. Q27291165

81. 2,5-diamino-2-(difluoromethyl)pentanoic Acid,hydrochloride

82. 2,5-bis(azanyl)-2-[bis(fluoranyl)methyl]pentanoic Acid Hydrochloride

83. 2,5-diamino-2-(difluoromethyl)pentanoic Acid Hydrochloride;eflornithine Hcl

84. 2,5-diamino-2-(difluoromethyl)pentanoic Acid, Monohydrochloride

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 218.63 g/mol
Molecular Formula C6H13ClF2N2O2
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count6
Rotatable Bond Count5
Exact Mass218.0633617 g/mol
Monoisotopic Mass218.0633617 g/mol
Topological Polar Surface Area89.3 Ų
Heavy Atom Count13
Formal Charge0
Complexity166
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Treatment of facial hirsutism in women.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Trypanocidal Agents

Agents destructive to the protozoal organisms belonging to the suborder TRYPANOSOMATINA. (See all compounds classified as Trypanocidal Agents.)


Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)


Ornithine Decarboxylase Inhibitors

Substances and drugs that inhibit or block the activity of ORNITHINE DECARBOXYLASE. (See all compounds classified as Ornithine Decarboxylase Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Decarboxylase Inhibitor [EPC]; Decarboxylase Inhibitors [MoA]; Antiprotozoal [EPC]
5.3 ATC Code

D11AX


Listed Suppliers

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Rusan Pharma

India
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  • WHO-GMP

Virtual BoothRusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Eflornithine Hydrochloride

About the Company : Rusan Pharma is a global pharmaceutical company specializing in addiction and pain management, manufacturing APIs and formulations for controlled substances. Its facilities are GMP...

Rusan Pharma is a global pharmaceutical company specializing in addiction and pain management, manufacturing APIs and formulations for controlled substances. Its facilities are GMP-approved by multiple international agencies, and it holds CEP approval for key APIs like Buprenorphine, Fentanyl, and Methadone. Rusan also produces transdermal patches, depot injections, and implants for long-acting treatments. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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EUROAPI

France
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  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Eflornithine Hydrochloride

About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...

EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio of around 200 products, covering a wide range of technologies and innovative molecules through CDMO activities. Supported by 3,650 employees, strong R&D capabilities, and six manufacturing sites in Europe, EUROAPI delivers high-quality API manufacturing to customers in more than 80 countries. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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03

HRV Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Eflornithine

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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  • WHO-GMP

Virtual BoothWillow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.

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Eflornithine Hydrochloride

About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...

Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 states as a drug wholesaler and NABP accreditation since 2007, Willow Birch Pharma delivers top-quality products at competitive prices with unparalleled service and regulatory support nationwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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05

Biotechnica DWC

Algeria
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Biotechnica DWC

Algeria
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Eflornithine HCl

About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...

BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies all over the world. Biotechnica is an integrated global solution provider from design to implementation of industrial projects in the areas of Pharmaceuticals,Agri-food ,Cosmetics and Nutrition. With more than 25 years of experience in the assembly of plants, particularly in the pharmaceutical sector, we accompany our customers in the various stages of their projects – E-CTD Dossieers – Raw Materiels – Equipements – Accessories – Packaging – Distribution.
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06

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Eflornithine Hydrochloride

About the Company : Micro Orgo Chem is a pharmaceutical establishment, manufacturing niche Active Pharmaceutical Ingredients (API). Founded in 1992, we have a mission of providing high quality drugs t...

Micro Orgo Chem is a pharmaceutical establishment, manufacturing niche Active Pharmaceutical Ingredients (API). Founded in 1992, we have a mission of providing high quality drugs to the market. Over these years, we have expanded our product portfolio to hormones, narcotics analgesics, steroids and more. We aspire to use our experience of over two decades to continue to provide Micro Orgo Chem’s finest drugs to those in need.
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OmnisMed Pharmaceuticals

United Kingdom
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OmnisMed Pharmaceuticals

United Kingdom
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Eflornithine

About the Company : OmnisMed Pharmaceuticals believes that good healthcare must be accessible to everyone; That is the core of our philosophy. We are experts in providing a wide range of high-quality ...

OmnisMed Pharmaceuticals believes that good healthcare must be accessible to everyone; That is the core of our philosophy. We are experts in providing a wide range of high-quality pharmaceutical products, highly tested and approved controlled drugs, and fully certifiable medical devices. All our suppliers hold several GMPs and certifications which are readily accepted by developed and developing markets. The high daily manufacturing capacity of our facilities and our distribution network allows us to quickly fulfill large orders and ensure our manufacturing process is cost-effective.
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EFLORNITHINE HYDROCHLORIDE

US Patent Number : 12582625

Drug Substance Claim :

Drug Product Claim :

Application Number : 215500

Patent Use Code : U-4444

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-02-12

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EFLORNITHINE HYDROCHLORIDE

Exclusivity Code : NP

Exclusivity Expiration Date : 2026-12-13

Application Number : 215500

Product Number : 1

Exclusivity Details :

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EFLORNITHINE HYDROCHLORIDE

Exclusivity Code : ODE-462

Exclusivity Expiration Date : 2030-12-13

Application Number : 215500

Product Number : 1

Exclusivity Details :

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Eflornithine Hydrochloride manufacturers, exporters & distributors 1

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API | Excipient name

Eflornithine Hydrochloride

Synonyms

68278-23-9, Eflornithine hcl, Dfmo, Dl-alpha-difluoromethylornithine hydrochloride, Eflornithinehydrochloride, 2-(difluoromethyl)-dl-ornithine monohydrochloride

Cas Number

68278-23-9

Unique Ingredient Identifier (UNII)

UO07O10TCJ

About Eflornithine Hydrochloride

An inhibitor of ornithine decarboxylase, the rate limiting enzyme of the polyamine biosynthetic pathway.

Eflornithine Hydrochloride Manufacturers

A Eflornithine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eflornithine Hydrochloride, including repackagers and relabelers. The FDA regulates Eflornithine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eflornithine Hydrochloride 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 Eflornithine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

Eflornithine Hydrochloride Suppliers

A Eflornithine Hydrochloride supplier is an individual or a company that provides Eflornithine Hydrochloride active pharmaceutical ingredient (API) or Eflornithine Hydrochloride finished formulations upon request. The Eflornithine Hydrochloride suppliers may include Eflornithine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Eflornithine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

Eflornithine Hydrochloride USDMF

A Eflornithine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Eflornithine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Eflornithine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Eflornithine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Eflornithine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Eflornithine Hydrochloride USDMF includes data on Eflornithine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eflornithine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Eflornithine Hydrochloride suppliers with USDMF on PharmaCompass.

Eflornithine Hydrochloride WC

A Eflornithine Hydrochloride written confirmation (Eflornithine Hydrochloride WC) is an official document issued by a regulatory agency to a Eflornithine Hydrochloride manufacturer, verifying that the manufacturing facility of a Eflornithine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eflornithine Hydrochloride APIs or Eflornithine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Eflornithine Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Eflornithine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Eflornithine Hydrochloride NDC

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 Eflornithine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Eflornithine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Eflornithine Hydrochloride 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Eflornithine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eflornithine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Eflornithine Hydrochloride suppliers with NDC on PharmaCompass.

Eflornithine Hydrochloride GMP

Eflornithine Hydrochloride 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 Eflornithine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Eflornithine Hydrochloride GMP manufacturer or Eflornithine Hydrochloride GMP API supplier for your needs.

Eflornithine Hydrochloride CoA

A Eflornithine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Eflornithine Hydrochloride's compliance with Eflornithine Hydrochloride specifications and serves as a tool for batch-level quality control.

Eflornithine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Eflornithine Hydrochloride 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.

Eflornithine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Eflornithine Hydrochloride EP), Eflornithine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eflornithine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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