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YY/T 1776-2021 English PDF

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US$189.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1776-2021: Determination of lactide monomer residual in poly (lactide) for surgical implants
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1776-2021	189	Add to Cart	3 days	Determination of lactide monomer residual in poly (lactide) for surgical implants	Valid

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Basic data

Standard ID: YY/T 1776-2021 (YY/T1776-2021)
Description (Translated English): Determination of lactide monomer residual in poly (lactide) for surgical implants
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Word Count Estimation: 10,199
Issuing agency(ies): State Drug Administration

YY/T 1776-2021: Determination of lactide monomer residual in poly (lactide) for surgical implants

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Determination of lactide monomer residual in poly (lactide) for surgical implants ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standards The content of lactide monomer in polylactic acid material of surgical implant Determination of Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

Foreword Ⅰ 1 Scope 1 2 Normative references 1 3 General 1 4 Method summary 1 5 Test method 1 6 Results processing and expression 4 Appendix A (Normative Appendix) Adaptability Requirements for Gas Chromatography 5 Reference 7

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee for Surgical Implants and Orthopaedic Devices (SAC/TC110). Drafting organizations of this standard. Lifetech (Shenzhen) Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Liu Yanwen, Li Yunfei, Li Yuan, Ma Jinzhu. The content of lactide monomer in polylactic acid material of surgical implant Determination of

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 article Pieces. 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℃~30℃. 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-γ-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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1776-2021_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1776-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1776-2021_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1776-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.