YY/T 1776-2021Determination of lactide monomer residual in poly (lactide) for surgical implants (English PDF)
外科植入物聚乳酸材料中丙交酯单体含量的测定
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 1776-2021 is the English-translated version of 外科植入物聚乳酸材料中丙交酯单体含量的测定.
YY/T 1776-2021 is the Chinese pharmaceutical industry standard that gives the method for determining residual lactide monomer in the polylactic acid used for surgical implants, the unreacted monomer left from polymerization.
It sets out the reagents, the dissolution of the material, the chromatographic determination and the calculation of the residue, so that the amount can be checked against the specification.
It applies to polylactic acid materials that dissolve completely in dichloromethane and chloroform. Issued on 9 March 2021, it has applied since 1 April 2022.
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Document preview — YY/T 1776-2021
National Standard of the People's Republic of China
- Classification
- C 35
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 General
- 4 Method summary
- 5 Test method
- 6 Results processing and expression
- Appendix A (Normative Appendix) Adaptability Requirements for Gas Chromatography
- Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the detection method for the residual lactide monomer in the polylactic acid material of surgical implants.
This standard applies to polylactic acid materials that can be completely dissolved by dichloromethane and chloroform.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 8170 Numerical rounding rules and the expression and determination of limit values Chinese Pharmacopoeia (2015 edition four)
3 General
The room temperature in this standard, unless otherwise specified, should be 10°C~30°C.
The containers used in this standard shall be borosilicate glass containers if there are no special regulations.
The measurement involved in this standard should be measured with a pipette or pipette that meets the accuracy requirements specified by the corresponding national standards.
4 Method summary
The polylactic acid material is formed by the ring-opening polymerization of lactide monomer, and the reaction process is a reversible reaction. Use chloroform or dichloromethane As a solvent to completely dissolve the sample, after adding the internal standard, the precipitating agent is used to completely precipitate the polylactic acid material from the solution, and the internal standard substance, lactide The monomer remains in the solution. After centrifugation, the supernatant is taken and tested with a gas chromatograph-hydrogen flame ion detector to exclude polylactic acid materials. Material degradation interferes with the lactide content test.
Note. This standard gives typical test conditions and processing procedures, and companies can also use other methods that have been verified by methodology and meet the requirements of system applicability. method.
5 Test method
5.1 Reagents and materials
5.1.1 Selection of standard products. Choose a suitable monomer standard product according to the actual sample, and the purity should be >=98%.
5.1.2 Internal standard substances. 2,6-dimethyl-gamma-pyrone and other suitable internal standard substances, the purity should be >=99%.
5.1.3 Solvent. dichloromethane/trichloromethane (chromatographically pure), acetone (chromatographically pure), cyclohexane (chromatographically pure).
5.1.4 Precipitant (acetone and cyclohexane). acetone and cyclohexane are added to the beaker at a volume ratio of 3.16, and mixed evenly with a glass rod That's it.
Note 1.Precipitating agent can choose other poor solvents or mixed poor solvents that can meet the requirements of precipitating polylactic acid.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
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