CA HDKN Wacker YA47895 & YA47897 PDF
CA HDKN Wacker YA47895 & YA47897 PDF
CA HDKN Wacker YA47895 & YA47897 PDF
Technical data Test method/Inspection condition Unit Measured value Lower limit Upper limit
Surface BET DIN 9277/66132 PV09001 m²/g 200 175 225
pH-value in suspense EN ISO 787/9 PV09005 nounit 4,1 3,8 4,3
Sieve residue >40 µm EN ISO 787-18 PV09004 % 0,000 0,000 0,030
Loss on ignition according USP % 0,4 0,0 2,0
Loss on drying according USP % 0,2 0,0 1,5
Assay (Content silicon dioxide) according USP % 100,2 99,0 100,5
Content arsenic (As) according USP/AAS ppm <3 - 3
Content chlorine (Cl) according EP mg/kg < 250 - 250
Identity A and B according USP - positive - -
Test methods are in accordance with the specification requirements for "Colloidal Anhydrous Silica" in the current version of EP and for "Colloidal Silicon Dioxide" in the current version of USP.
This product meets the purity requirements of the monograph "Colloidal Anhydrous Silica" as stated in the current version of the British Pharmacopeia and of the monograph "Colloidal Silicon Dioxide" as stated
in the current version of the Indian Pharmacopeia.
This product meets the purity requirements for E 551 according to the Commission Regulation (EU) No. 231/2012 and for INS 551 according to the current FCC and JECFA monographs.
BSE/TSE:
This product is not derived from human or animal origin and for its manufacture no intermediates and/or auxiliary agents which are of human or animal origin are used.
Residual solvents:
Solvents as stated in "Guideline for residual solvents (CPMP/ICH/283/95)" of the current version of EP are not used for the manufacture of this product.
This product is manufactured in a dedicated production unit at the site Wacker Chemie AG, Friedrich-von-Heyden-Platz 1, 01612 Nünchritz, Germany.
Production, packaging and quality control comply with the principles of the "IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients". Production, packaging and quality control of this
product are certified according to ISO 9001:2008 and HACCP.
Technical data Test method/Inspection condition Unit Measured value Lower limit Upper limit
Surface BET DIN 9277/66132 PV09001 m²/g 201 175 225
pH-value in suspense EN ISO 787/9 PV09005 nounit 4,1 3,8 4,3
Sieve residue >40 µm EN ISO 787-18 PV09004 % 0,000 0,000 0,030
Loss on ignition according USP % 0,4 0,0 2,0
Loss on drying according USP % 0,1 0,0 1,5
Assay (Content silicon dioxide) according USP % 100,0 99,0 100,5
Content arsenic (As) according USP/AAS ppm <3 - 3
Content chlorine (Cl) according EP mg/kg < 250 - 250
Identity A and B according USP - positive - -
Test methods are in accordance with the specification requirements for "Colloidal Anhydrous Silica" in the current version of EP and for "Colloidal Silicon Dioxide" in the current version of USP.
This product meets the purity requirements of the monograph "Colloidal Anhydrous Silica" as stated in the current version of the British Pharmacopeia and of the monograph "Colloidal Silicon Dioxide" as stated
in the current version of the Indian Pharmacopeia.
This product meets the purity requirements for E 551 according to the Commission Regulation (EU) No. 231/2012 and for INS 551 according to the current FCC and JECFA monographs.
BSE/TSE:
This product is not derived from human or animal origin and for its manufacture no intermediates and/or auxiliary agents which are of human or animal origin are used.
Residual solvents:
Solvents as stated in "Guideline for residual solvents (CPMP/ICH/283/95)" of the current version of EP are not used for the manufacture of this product.
This product is manufactured in a dedicated production unit at the site Wacker Chemie AG, Friedrich-von-Heyden-Platz 1, 01612 Nünchritz, Germany.
Production, packaging and quality control comply with the principles of the "IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients". Production, packaging and quality control of this
product are certified according to ISO 9001:2008 and HACCP.