Korea FDA just published a compilation of analytical methods document!

Confirmatory Testing & Analytical Challenges
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Today Korean FDA published a compilation document of analytical methods. Development was conducted through a research project conducted by the MFDS. I believe it’s the first of its kind.
The document is, for now, available in Korean, but that doesn’t stop us from using google translators, right?

When applying the analysis methods outlined in this guide, please use after validating or verifying them with an appropriate method. Please note that the information presented may be changed according to the development of science and technology in the related field in the future and may differ from the MFDS’s policy or direction of review

The contents are as follows:

  1. NDMA Analysis Method for Ranitidine Hydrochloride Raw Materials and Finished Drugs (Single Drug)
  2. NDMA Analysis Method in Nizatidine Drug Substance
  3. NDMA Analysis Method in Nizatidine Finished Drug
  4. NDMA Analysis Method in Metformin Drugs
  5. Analysis Method of 4-Chloroaniline in Acetaminophen
  6. MNP Analysis Method for Rifampicin Raw Materials and Finished Drugs
  7. AZBT Analysis Method among Sartan-type Drug Substances
  8. Simultaneous Analysis of NDMA and NDEA in Entacapone
  9. MNP Analysis method in Rifampicin Complex (2-component, 4-component)
  10. Simultaneous Analysis method for 11 nitrosamines in Sartan-type Drugs
  11. Assay for 2-Chloroethanol in Capsules
  12. Simultaneous Analysis method for NDMA and NDEA in Sartans [HS-GC-MS/MS]
  13. Simultaneous Analysis method for NDMA and NDEA in Sartans [SPE-GC-MS/MS]
  14. Simultaneous Analysis of NDMA and NDEA in Sartans [Direct-GC-MS/MS]
  15. Method for Simultaneous Analysis of Alkyl Sulphonic Acid Esters in Drug Substances
  16. Method for Simultaneous Analysis of Alkyltoluenesulfonates in Drug Substances
  17. Simultaneous Analysis Method for Alkylbenzenesulfonates in Drug Substances
  18. Analytical Method for Alkylsulfonic Acid Esters in Methanesulfonic Acid in Drug Substances
  19. Analysis method for Methanesulfonyl Chloride in Methanesulfonic Acid in Drug Substances
  20. Assay for NDMA in Desvenlafaxine
  21. Analysis of NDMA in Chlorpheniramine Maleate
  22. Assay for NDMA in Trimebutine Maleate

Link: https://www.mfds.go.kr/brd/m_218/view.do?seq=33517

Original document Korean:
의약품+중+불순물+분석법+자료집_221031.pdf (738.4 KB)

English version:
MFDS_Analytical+Methods+for+the+Determination+of+Mutagenic+Impurities+in+DSs+or+DPs_230127.pdf (459.9 KB)

@trust_user_a @trust_user_b @trust_user_c

9 Likes
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@Minkyung @Ruth_Lee FYI

1 Like
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Hi Naiffer,

The link which was provided here is not working.

So, kindly provide it ones again.

Regards,
MB.

4

Hi Naiffer,

Looks like they have an English version after all when you click on guideline from the main page

식품의약품안전처?

Copy attached

MFDS_Analytical+Methods+for+the+Determination+of+Mutagenic+Impurities+in+DSs+or+DPs_230127.pdf (459.9 KB)

3 Likes
5

Thank you for sharing this English version!

6

MFDS_Analytical+Methods+for+the+Determination+of+Mutagenic+Impurities+in+DSs+or+DPs_230127.pdf (459.9 KB)

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thank you, Naiffer! I will also push this notification to the APAC team.

1 Like
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Please note there is a difference between the English version and the one in Korean in the number of methods described (17 vs 22). In any case, thanks for sharing!

2 Likes
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Yes. The following methods are only in the Korean version:

NDMA in Desvenlafaxine
NDMA in Chlorpheniramine Maleate
NDMA in Trimebutine Maleate

whilst the following is only in the English version

N-nitroso-varenicline in varenicline

but it saves someone translating the 89 pages and more importantly the same organisation publishes both the Korean and English versions so there is no misinterpretation

2 Likes
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Thanks for Sharing.

Regards,
MB.

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The link is working on my side. I included the file in the post now. Thanks

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Thanks @shinKim for sharing the file!

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Last January, the Korean Ministry of Food and Drug Safety (MFDS) published a reference document provide pharmaceutical industry with the information about the analysis methods to support self-evaluation and testing of mutagenic impurities during the manufacturing processes. The analysis methods in this document were developed and validated for the determination of mutagenic
impurities in drug substances or drug products. The analysis methods were prepared in the research studies conducted or funded by MFDS.

We got access to a full English version here:
NIFDS Guideline Analytical Methods for the Determination of Mutagenic Impurities in Drug Substances or Drug Products Jan-2023.pdf (441.4 KB)

image

@trust_user_a @trust_user_b @trust_user_c

6 Likes
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Thank you for sharing.
Kind regards!