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纯正堂出事了啊,有谁知道如何检验酒石酸吗?
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[转帖]：http://www.westyx.com/bbs/read.php?tid=31693 纯正堂出事了? 广西柳州纯正堂制药厂在生产维C银翘片中存在4项涉嫌违规行为，广西壮族自治区食品药品监督管理局已收回柳州纯正堂制药厂片剂《药品生产质量管理规范》(即GMP)证书，经整改合格后可重新申请。 记者2日从广西壮族自治区食品药品监督管理局获悉，根据群众举报，国家食品药品监督管理局于3月22日赶赴柳州，对纯正堂制药厂进行突击检查，发现这家制药厂在生产维C银翘片过程中存在4种涉嫌违规行为：投料产出数不符，原本只产30万片的原料，实产超过40万片；在对原材料的加工过程中，没有按照规定流程提取挥发油的流程记录；销售与实际生产数据不吻合；产品中出现原配方中未包括的食品添加剂酒石酸的成分。 |
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polycao
金虫 (小有名气)
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- 注册: 2005-12-06
- 专业: analytical chemistry
USP28
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Tartaric Acid C4H6O6 150.09 Butanedioic acid, 2,3-dihydroxy-; Butanedioic acid, 2,3-dihydroxy-, [R-(R*,R*)]-. Tartaric acid; L -(+)-Tartaric acid [526-83-0] and [87-69-4]. » Tartaric Acid, dried over phosphorus pentoxide for 3 hours, contains not less than 99.7 percent and not more than 100.5 percent of C4H6O6. Packaging and storage— Preserve in well-closed containers. Identification— A: It responds to the tests for Tartrate á191ñ. B: When ignited, it gradually decomposes, emitting an odor resembling that of burning sugar (distinction from citric acid). Specific rotation á781Sñ : between +12.0 and +13.0. Test solution: 200 mg per mL, in water. Loss on drying á731ñ— Dry it over phosphorus pentoxide for 3 hours: it loses not more than 0.5% of its weight. Residue on ignition á281ñ : not more than 0.1%. Limit of oxalate— Nearly neutralize 10 mL of a solution of it (1 in 10) with 6 N ammonium hydroxide, and add 10 mL of calcium sulfate TS: no turbidity is produced. Sulfate á221ñ— To 10 mL of a solution (1 in 100) add 3 drops of hydrochloric acid and 1 mL of barium chloride TS: no turbidity is produced. Heavy metals, Method II á231ñ : 0.001%. Organic volatile impurities, Method I á467ñ : meets the requirements. Assay— Place about 2 g of Tartaric Acid, previously dried and accurately weighed, in a conical flask. Dissolve it in 40 mL of water, add phenolphthalein TS, and titrate with 1 N sodium hydroxide VS. Each mL of 1 N sodium hydroxide is equivalent to 75.04 mg of C4H6O6. Auxiliary Information— Staff Liaison : Catherine Sheehan, B.Sc., Scientist Expert Committee : (EMC) Excipients: Monograph Content USP28–NF23 Page 3097 Phone Number : 1-301-816-8262 |
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