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北京石油化工学院2026年研究生招生接收调剂公告
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weiyueyue

金虫 (小有名气)

[交流] 纯正堂出事了啊,有谁知道如何检验酒石酸吗?

[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)

USP28

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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