JT Baker® 4100-05 Talc, Powder, Multi-Compendial Grade, 2Kg Poly Bottle (Case of 4)
Item Number:JTB-4100-05
Manufacturer Part No:JT-4100-05
Manufacturer:Avantor
Units:2Kg Poly Bottle, Case of 4
Details
- 2Kg Poly Bottle, Case of 4
Product Specifications
| TEST | SPECIFICATION |
| Meets U.S.P Requirements | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Identification C | Passes Test |
| Microbial Limit - Total Aerobic Bacterial Count | <= 100 cfu/g |
| Microbial Limit - Total Molds and Yeasts | <= 50 cfu/g |
| USP - Acidity and Alkalinity | Passes Test |
| USP - Loss on Ignition | <= 7.0 % |
| USP - Water-Soluble Substances | <= 0.1 % |
| USP - Iron (Fe) | <= 0.25 % |
| USP - Lead (Pb) | <= 0.001 % |
| USP - Calcium (Ca) | <= 0.9 % |
| USP - Aluminum (Al) | <= 2.0 % |
| USP - Absence of Asbestos (Method B) | Passes Test |
| USP - Magnesium (as MgO) | 17.0 - 19.5 % |
| EP/BP - Free from Asbestos | Passes Test |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification C | Passes Test |
| EP/BP - Acidity or Alkalinity | Passes Test |
| EP/BP - Water-Soluble Substances | <= 0.2 % |
| EP/BP - Aluminum (Al) | <= 2.0 % |
| EP/BP - Calcium (Ca) | <= 0.90 % |
| EP/BP - Iron (Fe) | <= 0.25 % |
| EP/BP - Lead (Pb) | <= 10.0 ppm |
| EP/BP - Magnesium (Mg) | 17.0 - 19.5 % |
| EP/BP - Loss on Ignition | <= 7.0 % |
| EP/BP - Total Aerobic Microbial Count, cfu/g | <= 1000 |
| EP/BP - Total Yeast and Mold Count, cfu/g | <= 100 |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | |
| Suitable for Oral Administration | |
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Product Specifications
| TEST | SPECIFICATION |
| Meets U.S.P Requirements | |
| Meets B.P. Chemical Specifications | |
| Meets E.P. Chemical Specifications | |
| GMP Manufactured Product | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Identification C | Passes Test |
| Microbial Limit - Total Aerobic Bacterial Count | <= 100 cfu/g |
| Microbial Limit - Total Molds and Yeasts | <= 50 cfu/g |
| USP - Acidity and Alkalinity | Passes Test |
| USP - Loss on Ignition | <= 7.0 % |
| USP - Water-Soluble Substances | <= 0.1 % |
| USP - Iron (Fe) | <= 0.25 % |
| USP - Lead (Pb) | <= 0.001 % |
| USP - Calcium (Ca) | <= 0.9 % |
| USP - Aluminum (Al) | <= 2.0 % |
| USP - Absence of Asbestos (Method B) | Passes Test |
| USP - Magnesium (as MgO) | 17.0 - 19.5 % |
| EP/BP - Free from Asbestos | Passes Test |
| EP/BP - Identification A | Passes Test |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification C | Passes Test |
| EP/BP - Acidity or Alkalinity | Passes Test |
| EP/BP - Water-Soluble Substances | <= 0.2 % |
| EP/BP - Aluminum (Al) | <= 2.0 % |
| EP/BP - Calcium (Ca) | <= 0.90 % |
| EP/BP - Iron (Fe) | <= 0.25 % |
| EP/BP - Lead (Pb) | <= 10.0 ppm |
| EP/BP - Magnesium (Mg) | 17.0 - 19.5 % |
| EP/BP - Loss on Ignition | <= 7.0 % |
| EP/BP - Total Aerobic Microbial Count, cfu/g | <= 1000 |
| EP/BP - Total Yeast and Mold Count, cfu/g | <= 100 |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. | |
| Suitable for Oral Administration | |