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Acids and Bases
Salicylic acid, EMPROVE® ESSENTIAL Ph Eur,BP,USP, 1006319024
Availablity:
In stock
Catalog/Part Number:
1006319024
Brand:
MERCK
Supplier:
MERCK
Supplier Location:
GERMANY
Inventory Weight:
unavailable
Unit of Measurement:
Inventory Brochure:
unavailable
Catalog/Part Number:: 1006319024
₦659,460.00
Description
Analysis
Note
Assay (acidimetric; calculated on dried substance): 99.5 - 100.5
%
Assay (HPLC, calc.on dried substance): 98.0 - 102.0 %
Identity: passes test
Appearance of solution (10 %; ethanol 96 %): passes test
Chloride (Cl): ≤ 0.0100 %
Sulfate (SO₄): ≤ 0.0200 %
Related substances / HPLC (EP)(4-Hydroxybenzoic acid): ≤ 0.1 %
Related substances / HPLC (EP)(4-Hydroxyisophthalic acid): ≤ 0.05 %
Related substances / HPLC (EP)(Phenol): ≤ 0.02 %
Related substances / HPLC (EP)(Largest unspecified impurity): ≤ 0.05 %
Related substances / HPLC (EP) (Sum of all impurities): ≤ 0.2 %
Related substances / HPLC (USP)(4-Hydroxybenzoic acid): ≤ 0.1 %
Related substances / HPLC (USP)(4-Hydroxyisophthali
Related substances / HPLC (USP)(Phenol): ≤ 0.02 %
Related substances / HPLC (USP)(Largest unspecified impurity): ≤ 0.05 %
Related substances / HPLC (USP)(Sum of all impurities): ≤ 0.2 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Sulfated ash: ≤ 0.05 %
Loss on drying: ≤ 0.5 %
Elemental impurity specifications have been set considering ICH Q3D (Guideline
for Elemental impurities). Class 1-3 elements are not likely to be present
above the ICH Q3D option 1 limit, unless specified and indicated (*).
corresponds to Ph Eur, BP, USP
Technical Specifications
Related Categories |
APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Ingredients for Liquid Dosage Formulation, Liquid Dosage Forms Less... |
| grade | BP |
| Ph Eur | |
| USP | |
| vapor pressure | <1 hPa ( 100 °C) |
| autoignition temp. | 500 °C |
| potency | 1250-1580 mg/kg LD50, oral (Rat) |
| >2000 mg/kg LD50, skin (Rat) | |
| pH | 2.4 ( in H2O, saturated solution) |
| bp | 211 °C/1013 hPa |
| mp | 157-159 °C |
| transition temp | flash point 157 °C |
| solubility | 2 g/L |
| density | 1.443 g/cm3 at 20 °C |
| bulk density | 400‑500 kg/m3 |
| storage conditions | Store at +15°C to +25°C. |
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