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1、UDC 666.176 JAPANESE INDUSTRIAL STANDARD . Vials for Injection JIS R 352 I -1976 Translated and Published by Japanese Standards Association Printed in Japan 5 s COPYRIGHT Japanese Standards Association Licensed by Information Handling Services COPYRIGHT Japanese Standards Association Licensed by Inf
2、ormation Handling Services J I S R*3521i 7b I I 4933bO 0069430 9 W Translation without guarantee standard in Japanese is to be evidence i n the event of any doubt arising, the original COPYRIGHT Japanese Standards Association Licensed by Information Handling Services COPYRIGHT Japanese Standards Ass
3、ociation Licensed by Information Handling Services IJIS R*3521 76 m 4933608 00b9431 O I i UDC 666.176 JAPANESE INDUSTRIAL STANDARD J I S Vials for hjection R 3521-1976 (Reaffirmed : 197 9) 1. Scope This Japanese Industrial Standard specifies vials for injection in which medicines for medical treatme
4、nt are enclosed, hereinafter referred to as the it,dS“ 2. Classification Vials shall be classified in the two classes shown in Table 1 by their approximate inner volume (full volume). Table 1 Unit: ml Inner volume 3. Quality The quality of vials shall meet the requirements of Table 2. Applicable Sta
5、ndard: JIS Z 8801-Test Sieves Reference Standard: JIS Z 8203-S1 Units and the Use of their Miiltinles smd nf Certain =- - - -“u- - - - - - - - - - - - .- _ - - - - - - - - - - _ _- -. - _ _ other Units COPYRIGHT Japanese Standards Association Licensed by Information Handling Services COPYRIGHT Japan
6、ese Standards Association Licensed by Information Handling Services J I S R*352L 7b 4933608 0067432 2 m 2 R 3521-1976 Table 2 Wall filling To be well- balanced and uniform. - - Shape Appearance To be correct in shape, stable in seating, and without deformation in shape. To be colorless and transpare
7、nt. Almost no crachs clearly discernible by naked eye, and no perceivable foams, cords, stones, or other intermixed foreign matters. Surfaces of the mouth head section being smooth. Strain No remarkable interference colors by strain tester appearing. Alkali dissolution quantity The quantity of N/50
8、sulfuric acid consumed in the alkali dissolution test of 5.2 being within 2 m1/5 g. 4. Shape, Dimensions, and Mass The shape, dimensions, and mass of vials shall be as specified below: 4.1 The shape of vials shall be as shown in Fig. 1. Fig. 1 4.2 The dimensions and mass of vials shall be as specifi
9、ed in Table 3. COPYRIGHT Japanese Standards Association Licensed by Information Handling Services COPYRIGHT Japanese Standards Association Licensed by Information Handling Services bIS R83521 76 m 4933608 0069433 4 9 1 - Table 3 Unit: mm 4.3 The tolerances on the dimensions and mass of vials shall b
10、e as specified in Table 4. Table 4 Unt: mm Class No. 1 No. 2 Brim height Mouth Mouth Height inner outer diameter diameter t: 0.5 5 Oe35 5 0.3 k 0.3 5 0.5 2 0.35 k0.3 . 50.3 Barrel Mass diameter k 2.0 I k 0.4 I 0.4 I k2.5 5. Test Methods 5.1 Test Methods for Dime ions and Mass The dimensions of vials
11、 shall be measured at the positions shown in Fig. 2 by using vernier callipers with 1/20 mm vernier, and their mass shall be measured by using a even balance with a weighing capacity (l) of 100 g and a reciprocal sensibility (2 of 100 mg. I COPYRIGHT Japanese Standards Association Licensed by Inform
12、ation Handling Services COPYRIGHT Japanese Standards Association Licensed by Information Handling Services J I S R*3521 7b 4933608 00b9434 b 4 R 3521-1976 Fig. 2 Mouth outer diameter Brim height Remarks 1. The mouth inner diameter, mouth outer diameter, barrel diameter, and brim height shall be meas
13、ured at randomly chosen positions removed from seams. The mouth inner diameter shall be measured by inserting vernier callipers from the mouth crest by about 3 mm. The barrel diameter shall be measured at the middle of the barrel. 2. 3. Notes (l) The weighing capacity means the maximum measurable qu
14、anti-y as specified in the Measurement Law. (2) The reciprocal sensibility means the minimum measurable quan- tity as specified in the Measurement Law. 5.2 Test Method for Alkali Dissolution After thoroughly washing the inner and outer surfaces of the vial and then drying, pulverize it carefully in
15、an agate or steel mortar, take about 7 g of the powder with a size passing through the 840 um test sieve (Japanese Pharmacopeia Sieve No. 4) specified in JIS Z 8801 (Test Sieves) and does not pass through the 297 pm test sieve (Japanese Pharmacopeia sieve No. 5), put it in the 297 um test sieve (Jap
16、anese Pharmacopeia sieve No. 5) and immerse in a suitable container containing dis- tilled water, and after removing minute glass particles and the like attached on the glass pieces on the 297 um test sieve (Japanese Pharmacopeia sieve No. 5) by washing with gentle shaking for 1 min, further wash wi
17、th alcohol for 1 min, then dry at about 100C for 30 min, and let it cool in a desiccator. Correctly weigh out about 5 g of this powder into a 200 ml hard glass Erlenmeyer flask, add 50 ml water, gently shake and mix so that the powder disperse as uniformly as possible on the flask bottom, and after
18、heating the flask in a boiling water bath for 2 h with the flask covered with a small hard glass beaker or a hard watch glass, promptly let it cool to room temperature, andadd 3 drops of Methyl Red indicator to titrate with N/50 sulfuric acid. Separately, conduct a blank test by the same method. COP
19、YRIGHT Japanese Standards Association Licensed by Information Handling Services COPYRIGHT Japanese Standards Association Licensed by Information Handling Services J I S R*352L 7b E 4933b08 0069435 8 - 7 - - R 3521-1976 6. Inspection . inspection, and the decision on acceptability as a lot shall be m
20、ade according to the lot size, sampling method, sample size, and the criterion for judgment agreed upon between the partis concerned. Vials shall be inspected for their dimensions, mass, and quality by sampling 7. Marking 5. Each package of Vials shall be attached or inserted with a certificate indi
21、- cating the following items of information: Name of product , class, quantity, date of manufacture , lot number, manu- facturing companys name, and the ame of manufactory. Appendix The values of dimensions and mass specified in Table 3 of this standard may be altered until further notice within the
22、 ranges in the following table on agreement between the parties concerned. Unit: mm Class No. 1 No. 2 Brim Barrel Mass Mouth Mouth Height inner outer diameter diameter 45.0 to 12.0 to 19.5 to 3.3 to 23.5 to 18.0 to 57.0 to 12.0 to 19.5 to 3.3 to 25.5 to 22.7 to 59. O 13. O 19.9 4.3 27. O 27.5 (g) 47
23、, o 13. O 19.9 4.3 25. O 21. o height diameter COPYRIGHT Japanese Standards Association Licensed by Information Handling Services COPYRIGHT Japanese Standards Association Licensed by Information Handling Services I J I S R*3521 76 E 4933608 0069436 T E 1 R 3521-1976 Edition 1 Japanese Text Establish
24、ed by Minister of International Trade and Industry Date of Establishment: 1957-03-29 Date of Revision: 1976-03-01 Date of Reaffirmation: 1979-03-01 Date of Public Notice in Official Gazette: 1979-03-14 Investigated by: Japanese Industrial Standards Committee Divisional Council on Ceramics Technical
25、Committee on Vials This English translation is published by: Japanese Standards Association 1- 24, Akasaka 4, Minato- ku, Tokyo 107 Japan 0 JSA, 1986 Rinted i n Tokyo by Hohbunsha Co.,Lt& - COPYRIGHT Japanese Standards Association Licensed by Information Handling Services COPYRIGHT Japanese Standards Association Licensed by Information Handling Services