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1. 6020-87-7
2. 2-(1-methylguanidino)acetic Acid Hydrate
3. Creatine Hydrate
4. Creatine, Monohydrate
5. Creapure
6. Glycine, N-(aminoiminomethyl)-n-methyl-, Monohydrate
7. Creatine (monohydrate)
8. Mfcd00071582
9. 2-[carbamimidoyl(methyl)amino]acetic Acid;hydrate
10. 9603ln7r2q
11. N-amidinosarcosine Monohydrate
12. Unii-9603ln7r2q
13. Creatine-monohydrate
14. Schembl53010
15. Creatine Monohydrate 80 Mesh
16. Creatine Monohydrate, >=98%
17. Creatine Monohydrate 150 Mesh
18. Creatine Monohydrate 200 Mesh
19. Amy8957
20. Dtxsid10208954
21. Methylguanidoacetic Acid Monohydrate
22. S6023
23. Creatine Monohydrate [who-dd]
24. Creatine-[guanidino-13c] Monohydrate
25. N-amidinosarcosine Monohydrate
26. Akos002391125
27. Cs-w018178
28. Ds-9420
29. Hy-w017462
30. Ac-15066
31. Sy036143
32. Db-053557
33. Ft-0622269
34. A19430
35. D70219
36. Q-200892
37. Q27271832
38. Glycine, N-(aminoiminomethyl)-n-methyl-, Hydrate (1:1)
39. Creatine, United States Pharmacopeia (usp) Reference Standard
40. Glycine,n-(aminoiminomethyl)-n-(methyl-d3)-,monohydrate(9ci)
41. Glycine, N-(aminoiminomethyl)-n-(methyl-d3)-,monohydrate (9ci)
| Molecular Weight | 149.15 g/mol |
|---|---|
| Molecular Formula | C4H11N3O3 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 3 |
| Exact Mass | 149.08004122 g/mol |
| Monoisotopic Mass | 149.08004122 g/mol |
| Topological Polar Surface Area | 91.4 Ų |
| Heavy Atom Count | 10 |
| Formal Charge | 0 |
| Complexity | 134 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
API SUPPLIERS
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16538
Submission : 2003-04-02
Status : Inactive
Type : II
NDC Package Code : 51552-0489
Start Marketing Date : 2004-09-01
End Marketing Date : 2025-08-20
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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ABOUT THIS PAGE
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PharmaCompass offers a list of Creatine Monohydrate 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 Creatine Monohydrate manufacturer or Creatine Monohydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Creatine Monohydrate manufacturer or Creatine Monohydrate supplier.
PharmaCompass also assists you with knowing the Creatine Monohydrate API Price utilized in the formulation of products. Creatine Monohydrate API Price is not always fixed or binding as the Creatine Monohydrate Price is obtained through a variety of data sources. The Creatine Monohydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Creatine Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Creatine Monohydrate, including repackagers and relabelers. The FDA regulates Creatine Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Creatine Monohydrate 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 Creatine Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Creatine Monohydrate supplier is an individual or a company that provides Creatine Monohydrate active pharmaceutical ingredient (API) or Creatine Monohydrate finished formulations upon request. The Creatine Monohydrate suppliers may include Creatine Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Creatine Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Creatine Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Creatine Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Creatine Monohydrate DMFs exist exist since differing nations have different regulations, such as Creatine Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Creatine Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Creatine Monohydrate USDMF includes data on Creatine Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Creatine Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Creatine Monohydrate suppliers with USDMF 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 Creatine Monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Creatine Monohydrate 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 Creatine Monohydrate 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 Creatine Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Creatine Monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Creatine Monohydrate suppliers with NDC on PharmaCompass.
Creatine Monohydrate 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 Creatine Monohydrate 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 Creatine Monohydrate GMP manufacturer or Creatine Monohydrate GMP API supplier for your needs.
A Creatine Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Creatine Monohydrate's compliance with Creatine Monohydrate specifications and serves as a tool for batch-level quality control.
Creatine Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Creatine Monohydrate 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.
Creatine Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Creatine Monohydrate EP), Creatine Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Creatine Monohydrate USP).
