1、MI L-T-5 1023D 29 December 1967 SUPERSEDING MI L-T-5 1023C(MU) 29 September 1966 MILITARY SPECIFICATION TABLETS, COMPOUND 34 This specification is mandatory for use by ali Departments and Agencies of the Department of Defense. 1. SCOPE 1.1 This specification covers tablets containing Compound 34, p-
2、amino-o- e thoxy- Beet or Cane. STANDARDS MI LI TARY - MIL-STD-105 - Sampling Procedures and Tables for Inspection by Attributes. pment and Storage. MIL-STD-129 - Marking for Sh DRAW I N GS US ARMY MUNITIONS COMMAP D B5-77-168 DL136-13-5Q0 - Tester, Friability Q33 - Vial, Green, Assembly and Detail.
3、 - FSC 6665 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MI L-T-51023D (Copies of specifications, standards, drawings, and publications required by suppliers in connection with specific procurement functions should be obtained from the procuring a
4、ctivity or as directed by the contracting officer.) 2.2 Other publications. The following documents form a part of this specifi- cation to the extent specified herein. Unless otherwise indicated, the issue in effect on date of invitation for bids or request for propossal shall apply. UN IF ORM CLASS
5、 IF ICATI ON COMMITTEE . Uniform Freight CI assi fication (Application for copies of these ratings, rules and regulations should be addressed to Uniform Classification Committee, 202 Union Station, 516 West Jackson Boulevard, Chicago, Illinois 66606.) THE UNITED STATES PHARMACOPOEIAL CONVENTION, INC
6、. - Pharmacopeia of the United States, XVI Revision (Copies of the US Pharmacopeia may be obtained from the Mack Publishing Company, Easton, Pennsylvania 18042,) AMERICAN SOCIETY FOR TESTING AND MATERIALS ASTM Standard D1193-56 - Reagent Water. (Application for copies should be addressed to the Amer
7、ican Society for Testing and Materials, 1916 Race Street, Philadelphia, Pennsylvania 19103.) 3. REQUIREMENTS 3.1 Tablet composition. Each tablet shall be double convex, 7/32 - + 1/32 inch in diameter, (see 6.4) and shall cansist of: 2 Provided by IHSNot for ResaleNo reproduction or networking permit
8、ted without license from IHS-,-,-MI L-T-5 1 023D Materia I Compound 34“ Descri p t io n Mil I igrams Recrystal I ized, melting at 250 to 255OC and indicating no absorb- ance from 460 to 700 my when tested as a O. O01 M methanol solution against a methanol blank 2.5 - + 0.2 Magnesium stearate Technic
9、al grade O. 5 Sugar JJJ-S-791, type l(b) (2) remainder *When Compound 34 is furnished by the Government, the supprier shall reprocess the material to meet the above requirements. 3.2 Assembly. The tablets shall be assembled into vials in accordance with Drawing B5-77- 168. 3.3 Compound 34 content, A
10、fter aging for two weeks at 65 -t- 2OC, the tablet sbm (mg) of Compound 34 when tested in accordance with 4.2,4.F. 3.4 Disintegration time. Before and after aging for two weeks at 65 -i- 2OC, the tablet shall dissolve in no more than 10 minutes when tested in accordance with 4.2.4.3. 3.5 Friability.
11、 Before and after aging for two weeks at 65O + 2OC, the tablet shall lose no more than 5 percent in weight when tested in accordance with 4.2.4.4. 4. QUALITY ASSURANCE PROV 4.1 Responsibility for inspection. 4.1. i Suppliers responsibility. SIONS Jnless otherwise specified in the contract or purchas
12、e order, requirements as may utilize his the supplier is responsible for the performance of all inspection specified herein. Except as otherwise specified, the supplier own facilities or any commercial laboratory acceptable to the %overnment. The Government reserves the right to perform any of the i
13、nspections set forth in the specification where such inspections are deemed necessary to assure suppl es and savices conform to prescribed requirements. 3 -, Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-T-53023D 66 U 3777706 0337730 T U - MI L
14、-T-5 1023D 4.1.2 .Objective evidence. The supplier shall provide objective evidence acceptable to the contracting officer that the requirements of 3.1 und section 5 for which specific inspection ha5 not been provided in this specification have been satisfied. 4.2 Regular production. =i . =?c 4.2.1 L
15、otting. A lot shall consist of the vials of Compound 34 produced by one manufacturer, from the same materials, and under essential l y the same manufacturing conditions and containing no more than one butch of Compound 34 (see 6.3). 4.2.2 Sampling. 4.2.2.1 For examination. Sampl ing shal I be csnduc
16、fed in accordance with MIL-STD-105. 4.2.2.2 For test. Vials of Compound 34 shall be taken at. random from each lot for testing in accordance with.table 1. 4.2.3 Inspection. 4.2.3.1 For examination, Sample vials of Compound 34 shall be inspected in accordance with the classification of defects and MI
17、L-STD-105. 4.2.3.2 For tests. One tablet from each vial shall be used for each test in accordance -with 4.2.4 and table I. Table I. Sampling and testing Test Size Compound 34 Disintegration time Before aging After aging Friability Before aging After ag ing Sampling Inspection Level Ml L-STD- 1 05) A
18、QL Percent defect ive s4 s2 s4 s4 s4 s4 4 1 .o 2.5 1.0 1 .o 1 .o 1 .o Test Pa rag ra ph 4.2.4.1 4.2.4.2 4.2.4.3 4.2.4.4 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MTI-T-51023D 66 m 7777706 0337733 3 W I 4,23,3 Classification of defects. I Catego
19、ries Defects Cri.tica1:. None defined I Major: AQL 1 .O percent defective 1 o1 102 1 03 1 04 1 05 106 107 Minor: Vial cracked or broken Tablets broken or powdered Cork damaged or fit incorrect . Coating missing or color incorrect Wax dip missing or inadequate I nte rna I con tam i n ti on Component
20、missing r- .AQL.2.5 * percent defective 201 202 203 204 I Vial length and diameter incorrect Cotton missing or tablets loosely packed External contamination Marking missing or illegible 4.2.4 - Tests. Water in accordance with ASTM D1193 and reagent grade emicals shall be used throughout the tests. W
21、here applicable, blank deter- minations shall be run and corrections applied where significant. Tests shal be conducted as follows: 4.2.4.1 Form and size. Select tablets in accordance with 4.2.2.2 and inspect for compliance with 3.1 for form and size. After this test, return tablets to oriainal viui
22、s from which obtained. preparation of the standard concentration curve shall have a melting point between 250 to 255OC and when tested as a 0.001M methanol solution against a methanol blank shall indicate no absorbance in the 460 to 700 mp range. The standard concentration curve shall be prepared in
23、 the following manner: Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-MIL-T-51023D (1) Accurately weigh approximately 35 mg of Compound 34, dissolve it in approximately 70 milliliters (ml) of water in a 100 ml volumetric flask by shaking at room tem
24、perature over 1 hour. Dilute to exactly 100 mi with water and mix well. Transfer measured volumes of this standard solution, equivalent to approximately 1.5, 2.0, 2.5, 3.0, and 3.5 mg of Compound 34, to five 100 mi volumetric flasks. Add water to each, to bring the volume to 20 ml. Then treat each s
25、tandard as follows: (2) Adjust the acidity to pH 3 or less with hydrochloric acid. (Two drops of the concentrated acid has been found sufficient.) Cool to below 10C in an ice bath and add dropwise a 1 percent solution of sodium nitrite in water until a blue color is obtained on starch-iodide paper.
26、(Four to five drops have been found sufficient.) Add rapidly 5 ml of a solution (previously cooled to below 10C) con- taining 0.05 gram of resorcinol and 0.25 gram of sodium hydroxide. Swirl and let the mixture stand for 5 minutes in the ice bath. Dilute to exactly 100 ml with water and mix well. (3
27、) Without delay dilute 5 to 50 with water and measure the absorbence of this solution at 465 mp in a 1 centimeter cell versus water set to zero absorbence. (4) Plot absorbence versus mg Compound 34 on rectangular coordinate graph paper. A straight line shall result. This is the standard curve. (b) P
28、rocedure. Take one tablet and dissolve it in 20 ml of water in a 100 ml volumetric flask. Then follow the procedure for the preparation of standards beginning with 4.2.4.2(a)(2). From the standard curve, read the weight of Compound 34 in each tablet. 4.2.4.3 Disintegration before and after aging. Te
29、st each tablet with the disin- tegration apparatus and procedure described in the US Pharmacopeia, sixteenth revision, page 934. The acceptance/rejection criteria of this specification shall apply in lieu of the criteria specified in the US Pharmacopeia. 4.2.4.4 Friability before and after aging. Br
30、ush the sample tablets with a camels hair brush to remove all adherent powder, and weigh each tablet to the nearest O. 1 mg. Place the tablets in tubes mounted on the drive wheel of Tester, Friability Q33 (DL 136-13-500) and with the axis of the wheel horizontal, rotate at a speed not exceeding 4 +
31、1/4 rotations per minute (rpm) until the tablets have sustained 500 drops. Remove the tablets from the tube, brush thoroughly, and weigh each tablet to the nearest 0.1 mg. 6 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-5. PREPARATION FOR DELIVERY
32、5.1 Pcrckaaina, IeveIC. The vials of Compound 34 tablets shall be packaged to provide adequate protection against breakage or other damage in shipment from the supply source to the first receiving activity for immediate -. use . first domestic destination. Containers shal I be in compliance.w$h Unif
33、oEm Freight Classification rules or the regulations of other commop.carriers appl i- cable to the mode of transportation. - ._ -1 -: or order, unit packages, intermediate packages, and shipping containers shall be marked in accordance with MIL-STD-129. 5.3.1 identification markincl. Each packaae sha
34、l I be marked with the fol I ow ng : Tablets, Compound 34 Lot number Number of vials in Dackacle Manufacturer Date of manufacture. 6. NOTES 6.1 Intended use. The tablets covered bv this specification are intended for use in detector kits for the detection of G-agents. 6.3 Batch. A batch is defined a
35、s that auantitv of materiaf which has been subiected to SOM unit chemical OF physicaC mixing grqess fnferided fo make he ffnal product substanfially vnifom, I Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Project No. 6665-0148 Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-
