制药业中硅藻土的使用

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各位蒲友：
针对于在原料企业会经常涉及到硅藻土作为助滤剂使用，在制剂行业请问大家会使用到相应的硅藻土没？？？（是否在生物发酵制药行业会经常涉及呢???），那么对于硅藻土大家是使用到食品级的还是药典级的呢？？？下面一篇文献有详细讲到这个问题，供大家学习《Diatomite Filter Aid in cGMP Pharmaceutical Processing》http://www.advancedminerals.com/ ... a_reg._perspect.pdf

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Purified Siliceous Earth(选自USP38-NF33 SECOND SUPPLEMENT)

DEFINITION
Purified Siliceous Earth is a form of silica (SiO2 ) consisting of the frustules and fragments of diatoms, purified by calcining.

IMPURITIES
•   Loss on Ignition 733Sample:  1 g, previously dried
Analysis:  Ignite the Sample at 980 ± 25 for 1 h in a tared platinum or porcelain crucible.
Acceptance criteria:  NMT 2.0%

•  Leachable ArsenicSample solution:  To 10.0 g in a 250-mL beaker add 50 mL of 0.5 N hydrochloric acid, cover with a watch glass, and heat at 70 for 15 min. Cool, and decant through a Whatman No. 3 filter paper into a 100-mL volumetric flask. Wash the slurry with three 10-mL portions of water, preheated to 70, and dilute with water to volume.
Analysis:  A 3.0-mL portion of the Sample solution meets the requirements in Arsenic, Method 1 211.
Acceptance criteria:  NMT 10 μg/g

•  Leachable LeadSample:  A 10.0-mL portion of the Sample solution prepared in the test for Leachable Arsenic
Control:  10 mL of Diluted Standard Lead Solution in Lead 251
Analysis:  The Sample meets the requirements in Lead 251.
Acceptance criteria:  NMT 10 μg/g

•  Limit of Nonsiliceous SubstancesSample:  200 mg
Analysis:  Transfer the Sample to a tared platinum crucible, add 5 mL of hydrofluoric acid and 2 drops of dilute sulfuric acid (1 in 2), and evaporate gently to dryness. Cool, add 5 mL of hydrofluoric acid, evaporate again to dryness, and ignite to constant weight.
Acceptance criteria:  The weight of the residue is NMT 50 mg.

SPECIFIC TESTS
•   Loss on Drying 731Analysis:  Dry a sample at 105 for 2 h.
Acceptance criteria:  NMT 0.5%

•  Acid-Soluble SubstancesSample:  10.0 g
Analysis:  Digest the Sample with 50 mL of 0.5 N hydrochloric acid at 70 for 15 min, and filter. Wash the residue, adding the washings to the filtrate to obtain a total volume of 100 mL. Evaporate at 110 in a tared porcelain dish to dryness.
Acceptance criteria:  NMT 2.0% (weight of the dried residue is NMT 200 mg)

•  Water-Soluble SubstancesSample:  12.5 g
Analysis:  Place the Sample in a 500-mL conical flask, add 250 mL of water, and shake for 2 h at room temperature. Filter with the aid of vacuum, and again filter if necessary to obtain a clear filtrate. Evaporate in a tared platinum or porcelain dish, and dry at 110.
Acceptance criteria:  NMT 0.2% (weight of the residue is NMT 25 mg)

ADDITIONAL REQUIREMENTS
•  Packaging and Storage: Preserve in well-closed containers.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.


[td]

Topic/Question	Contact	Expert Committee
Monograph	Hong Wang, Ph.D. Senior Scientific Liaison (301) 816-8351	(EXC2010) Monographs - Excipients

USP38–NF33 Page 6862

北重楼

有药用级用药用级的比较好，没有就用食用级呗

懒虫9527

先收藏，Mark。谢谢分享