PHARMACEUTICAL PVC RIGID FILM QULITY STANDARD
The standard is applied to pharmaceutical PVC rigid film made of PVC resin, which is used for solid medicine (tablet, capsule) blister packaging.
【Appearance】 Take proper amount of PVC film, in the natural light bright place. Under visual inspecting, it should be colorless, transparent, uniform. Bump and wrinkle, oil, foreign bodies, perforation, impurities are not accepted. In every 100cm, fish eye that no more than 1.3mm should be not more than 3. Fish eye bigger than 1.3mm is not accepted.
Dimensions shall be taken 2 m per roll for inspection.
Take 2 kg of the sample after approval of appearance inspection on the balance, weigh precisely (Wa)， then put it in water with the distance between upper edge and water surface less than 10mm, weigh precisely (Wb)
Wa x D（water density）
The density should be 1.35~1.45g/cm3
Attachment：The density of water at different temperatures
Heating expansion rate: cut 2 pieces 120mX 120mm sample , in the center point , cut through with a blade, draw longitudinal AB, transverse CD with 100mm spacing.
The sample was placed on a flat metal plate (should not affect the free deformation of the sample), placed horizontally in the oven (100 土2) , heat for 10 minutes, then removed to cool at room temperature, and AB, CD was measured before and after the test. Then, according to the arithmetic mean value of AB CD of two samples, the expansion rate is calculated by the following equation, and the expansion rate should be within 6%.
S= L i
S-Heating expansion rate %
L i-distance of AB, CD before heating，mm
L 2-distance of AB, CD after heating，mm
【Dissolved matter】 Take appropriate amount, respectively take the area of 300cm, (divided into small pieces of 3cm length 0.3cm width ), wash with appropriate amount of water, put into a 500ml conical flask, add 200ml water, seal tightly. Put it in a high-pressure steam sterilizer, heat 121 土 2℃for 30 minutes, then remove, cool to room temperature; The other two parts were separately placed in a stopper conical flask, soak in 200ml of 65% ethanol (70± 2℃) and n-hexane (58± 2℃) for 2 hours, then remove, cool to room temperature, and supplemented with the same batch of solvent to the original volume as the test solution, and the same batch of water, 65% ethanol and n-hexane as the blank solution for later use.
Take 20ml water immersion solution, put it in 50ml NF colorimetric tube. According to the solution clarification test method (attached IX B), the solution should be clarified.
Heavy metal. take 20ml water immersion solution, add 2ml acetate buffer (pH3.5), and check.
(Appendix Pih First method), not exceeding one part per million.
Easy oxide. Precise amount of water immersion solution 20ml, precision add potassium permanganate titration solution (0.002mol/L) 20ml and dilute sulfuric acid 1ml, boil for 3 minutes, cool quickly, add potassium iodide 0.1g, leave in the dark for 5 minutes, titration with sodium thiosulfate titration solution (0.01mol/L), titration to near the end point, Add 0.25ml of starch indicator solution, continue to titrate until colorless, and take another blank solution with the same method, the difference between the two consumption of titration solution is not more than 1.5ml.
For non-volatile matter, take water, 65% ethanol, n-hexane leaching solution and blank solution 100ml each and place them in the evaporation dish with constant weight. Then dry them in a water bath and dry them at 105C for 2 hours. After cooling, they are accurately weighed. The difference between water non-volatile residue and blank residue shall not be more than 30.0mg, and the difference between 65%^ alcohol non-volatile residue and blank residue shall not be more than 30.0mg; The difference between the non-volatile residue and the blank residue of n-hexane shall not exceed 30.0mg.
【 barium 】 Take 2g of this product, put it in a crucible, slowly burn until carbonization. Let it cool, add 1ml hydrochloric acid to dissolve, steam dry, and burn at 800E to completely ash. Let cool, residue with 1mol/L hydrochloric acid 10ml dissolved, filtered, filtrate added 1ml dilute sulfuric acid, shake well, no turbidity.
【 Microbial limit】 Take 20cm of this product, cut into pieces, add pH7.0 sterile sodium chlorine-peptone buffer 100ml (if necessary can increase dilution), soak, shake, as the test solution.
【abnormal toxicity】 Take 500 μ l of this product (based on the internal surface area), cut it into 3cm ^ 0.3cm small pieces, add 50ml of 0.9% sodium chloride injection, sterilize it with damp heat at 110C for 30 minutes, take it out, cool it for standby, inject it intravenously, and determine it according to law (Appendix Xi C), which should meet the regulations. (this item is inspected every six months)
【Storage】 The inner package is sealed with a solid medical bag of low density polyethylene and kept in a clean and ventilated place.