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Chemistry

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Also known as: 557-05-1, Zinc distearate, Zinc octadecanoate, Octadecanoic acid, zinc salt, Metallac, Stearates
Molecular Formula
C36H70O4Zn
Molecular Weight
632.3  g/mol
InChI Key
XOOUIPVCVHRTMJ-UHFFFAOYSA-L
FDA UNII
H92E6QA4FV

Zinc Stearate
1 2D Structure

Zinc Stearate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
zinc;octadecanoate
2.1.2 InChI
InChI=1S/2C18H36O2.Zn/c2*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;/h2*2-17H2,1H3,(H,19,20);/q;;+2/p-2
2.1.3 InChI Key
XOOUIPVCVHRTMJ-UHFFFAOYSA-L
2.1.4 Canonical SMILES
CCCCCCCCCCCCCCCCCC(=O)[O-].CCCCCCCCCCCCCCCCCC(=O)[O-].[Zn+2]
2.2 Other Identifiers
2.2.1 UNII
H92E6QA4FV
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Aluminum Monostearate

2. Aluminum Tristearate

3. Ammonium Stearate

4. Calcium Stearate

5. Magnesium Stearate

6. Octadecanoic Acid

7. Sodium Stearate

8. Stearic Acid

2.3.2 Depositor-Supplied Synonyms

1. 557-05-1

2. Zinc Distearate

3. Zinc Octadecanoate

4. Octadecanoic Acid, Zinc Salt

5. Metallac

6. Stearates

7. Zn Stearate

8. Talculin Z

9. Stavinor Zn-e

10. Zinc Bisstearate

11. Metasap 576

12. Zinc Stearate W. S

13. Stearic Acid, Zinc Salt

14. Zinc Stearate [usp]

15. Stearic Acid Zinc Salt

16. H92e6qa4fv

17. Zinc Stearate (usp)

18. Hydense

19. Hytech

20. Mathe

21. Coad

22. Zinci Stearas

23. Zink Distearat

24. Unichem Zs

25. Zincum Stearinicum

26. 144188-98-7

27. Dibasic Zinc Stearate

28. Petrac Zn-41

29. Caswell No. 926

30. Synpro Stearate (van)

31. Witco Zinc Stearate Usp

32. Hsdb 212

33. Nsc-25957

34. Zinc Distearate, Pure

35. Einecs 209-151-9

36. Nsc 25957

37. Zinc Stearate, Total Dust

38. Unii-h92e6qa4fv

39. Epa Pesticide Chemical Code 077002

40. Zincstearate

41. Ai3-00388

42. Znst

43. Zinc;octadecanoate

44. Zinc Stearate, Respirable Fraction

45. Zinc Dioctadecanoate

46. Zinc(ii) Stearate

47. Zinc Stearate Spl

48. Zinc Stearate Tcg

49. Zinc Stearate Tcp

50. Einecs 257-363-5

51. Octadecanoic Acid, Zinc Salt, Basic

52. Octadecanoic Acid, Zinc Salt (2:1)

53. Lubimax Zinc Stearate

54. Rashayan Zinc Stearate

55. Starbld0000624

56. Ec 209-151-9

57. Schembl4923

58. Zinc Stearate [ii]

59. Zinc Stearate [mi]

60. Zinc Stearate [hsdb]

61. Zinc Stearate [inci]

62. Zinc Stearate [vandf]

63. Zinc Stearate [mart.]

64. Zinc Stearate [usp-rs]

65. Zinc Stearate [who-dd]

66. Dtxsid7027209

67. Zinc Stearate, Zno 12.5-14%

68. Mfcd00013031

69. Zinc Stearate [ep Monograph]

70. Zinc Stearate [usp Monograph]

71. Akos015915230

72. 51731-04-5

73. Ft-0645152

74. D06370

75. A830766

76. Q204923

2.4 Create Date
2005-07-19
3 Chemical and Physical Properties
Molecular Weight 632.3 g/mol
Molecular Formula C36H70O4Zn
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count4
Rotatable Bond Count30
Exact Mass630.456552 g/mol
Monoisotopic Mass630.456552 g/mol
Topological Polar Surface Area80.3 Ų
Heavy Atom Count41
Formal Charge0
Complexity196
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Therapeutic Uses

Zinc stearate is a mild antiseptic and astringent, and it has been used as a local soothing application for inflammatory and irritating skin diseases.

Cosmetic Ingredient Expert Review Panel; Final Report on the Safety Assessment of Lithium Stearate, Aluminum Distearate, Aluminum Stearate, Aluminum Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate and Zinc Stearate. Journal of the American College of Toxicology 1 (2): 143-77 (1982).


Zinc stearate is primarily used in pharmacuetical formulations as a lubricant in tablet and capsule manufacture at concentrations up to 1.5% w/w.

Rowe, R.C., Sheskey, P.J., Quinn, M.E.; (Eds.), Handbook of Pharmaceutical Excipients 6th edition Pharmaceutical Press, London, England 2009, p. 793


In dental cement

Kirk-Othmer Encyclopedia of Chemical Technology. 3rd ed., Volumes 1-26. New York, NY: John Wiley and Sons, 1978-1984., p. 7: 467 (1979)


4.2 Drug Warning

... Its use as dusting powder for infants is not recommended.

American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 84:24


5 Pharmacology and Biochemistry
5.1 Absorption, Distribution and Excretion

In humans with no excessive intake of zinc, the body burden half-time of absorbed radio-labelled zinc has been observed to range from 162 to 500 days. After parenteral administration of 65Zn2+, half-times ranged from 100 to 500 days. /Zinc ions/

European Chemicals Bureau; Risk Assessment Report on Zinc Distearate, CAS-No.: 557-05-1, 91051-01-3. EINECS-No.: 209-151-9, 293-049-4. Part II - Human Health p.37 (2004). Available from, as of March 24, 2011: https://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/zincdistearatereport074.pdf


Within certain limits, mammals can maintain the total body zinc and the physiologically required levels of zinc in the various tissues constant, both at low and high dietary zinc intakes. The sites of regulation of zinc metabolism are: absorption of Zn2+ from the gastrointestinal tract, excretion of zinc in urine, exchange of zinc with erythrocytes, release of zinc from tissue, and secretion of zinc into the gastrointestinal tract. Regulation of gastrointestinal absorption and gastrointestinal secretion probably contributes the most to zinc homeostasis. /Zinc ions/

European Chemicals Bureau; Risk Assessment Report on Zinc Distearate, CAS-No.: 557-05-1, 91051-01-3. EINECS-No.: 209-151-9, 293-049-4. Part II - Human Health p.38 (2004). Available from, as of March 24, 2011: https://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/zincdistearatereport074.pdf


5.2 Metabolism/Metabolites

Zinc is mostly bound to organic ligands rather than free in solution as a cation. Zinc is found in diffusible and non-diffusible forms in the blood and about 66% of the diffusible form of zinc in the plasma is freely exchangeable and loosely bound to albumin. A small amount of the non-diffusible form of zinc is tightly bound to 2-macroglobulin in the plasma and is not freely exchangeable with other zinc ligands. Zinc is incorporated into and dissociated from alpha2-macroglobulin only in the liver. /Zinc ions/

European Chemicals Bureau; Risk Assessment Report on Zinc Distearate, CAS-No.: 557-05-1, 91051-01-3. EINECS-No.: 209-151-9, 293-049-4. Part II - Human Health p.36 (2004). Available from, as of March 24, 2011: https://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/zincdistearatereport074.pdf


5.3 Biological Half-Life

For zinc, whole body: 162-500 days; [TDR, p. 1245]

TDR - Ryan RP, Terry CE, Leffingwell SS (eds). Toxicology Desk Reference: The Toxic Exposure and Medical Monitoring Index, 5th Ed. Washington DC: Taylor & Francis, 1999., p. 1245


In humans with no excessive intake of zinc, the body burden half-time of absorbed radio-labelled zinc has been observed to range from 162 to 500 days. After parenteral administration of 65Zn2+, half-times ranged from 100 to 500 days. /Zinc ions/

European Chemicals Bureau; Risk Assessment Report on Zinc Distearate, CAS-No.: 557-05-1, 91051-01-3. EINECS-No.: 209-151-9, 293-049-4. Part II - Human Health p.37 (2004). Available from, as of March 24, 2011: https://ecb.jrc.ec.europa.eu/DOCUMENTS/Existing-Chemicals/RISK_ASSESSMENT/REPORT/zincdistearatereport074.pdf


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25-Feb-2025
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ABOUT THIS PAGE

Looking for 557-05-1 / Zinc Stearate API manufacturers, exporters & distributors?

Zinc Stearate manufacturers, exporters & distributors 1

17

PharmaCompass offers a list of Zinc Stearate 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 Zinc Stearate manufacturer or Zinc Stearate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zinc Stearate manufacturer or Zinc Stearate supplier.

PharmaCompass also assists you with knowing the Zinc Stearate API Price utilized in the formulation of products. Zinc Stearate API Price is not always fixed or binding as the Zinc Stearate Price is obtained through a variety of data sources. The Zinc Stearate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Zinc Stearate

Synonyms

557-05-1, Zinc distearate, Zinc octadecanoate, Octadecanoic acid, zinc salt, Metallac, Stearates

Cas Number

557-05-1

Unique Ingredient Identifier (UNII)

H92E6QA4FV

Zinc Stearate Manufacturers

A Zinc Stearate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zinc Stearate, including repackagers and relabelers. The FDA regulates Zinc Stearate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zinc Stearate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Zinc Stearate Suppliers

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

click here to find a list of Zinc Stearate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Zinc Stearate USDMF

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

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

click here to find a list of Zinc Stearate suppliers with USDMF on PharmaCompass.

Zinc Stearate CEP

A Zinc Stearate CEP of the European Pharmacopoeia monograph is often referred to as a Zinc Stearate Certificate of Suitability (COS). The purpose of a Zinc Stearate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zinc Stearate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zinc Stearate to their clients by showing that a Zinc Stearate CEP has been issued for it. The manufacturer submits a Zinc Stearate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zinc Stearate CEP holder for the record. Additionally, the data presented in the Zinc Stearate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zinc Stearate DMF.

A Zinc Stearate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zinc Stearate 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 Zinc Stearate suppliers with CEP (COS) on PharmaCompass.

Zinc Stearate GMP

Zinc Stearate 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 Zinc Stearate 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 Zinc Stearate GMP manufacturer or Zinc Stearate GMP API supplier for your needs.

Zinc Stearate CoA

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

Zinc Stearate CoA mostly includes findings from lab analyses of a specific batch. For each Zinc Stearate 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.

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