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1.01142 SAFC

Ammonium chloride

EMPROVE® ESSENTIAL Ph Eur,BP,USP

Synonym: Ammonium chloride, Sal ammoniac

  • CAS Number 12125-02-9

  • Empirical Formula (Hill Notation) H4ClN

  • Molecular Weight 53.49

  •  EC Index Number 235-186-4

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms, Mineral Salts,
Agency/Method   BP
  Ph Eur
  USP
Quality Level   500
vapor pressure   1.3 hPa ( 30 °C)
autoignition temp.   >400 °C
potency   1410 mg/kg LD50, oral (Rat)
pH   4.7 (25 °C, 200 g/L in H2O, External MSDS)
mp   338 °C (sublimed; External MSDS)
solubility   372 g/L (External MSDS)
density   1.53 g/cm3 at 25 °C
bulk density   600‑900 kg/m3
InChI   1S/ClH.H3N/h1H;1H3
InChI key   NLXLAEXVIDQMFP-UHFFFAOYSA-N
storage conditions   Store at +5°C to +30°C.

Description

Analysis Note

Assay (argentometric; calculated on dried substance): 99.5 - 100.5 %
Identity: passes test
Appearance of solution: passes test
Acidity or alkalinity: passes test
pH-value (5 %; water): 4.6 - 6.0
Bromide, Iodide (Br,I): passes test
Sulfate (SO₄): ≤ 0.0150 %
Thiocyanate (SCN): passes test
Heavy metals (as Pb): ≤ 0.001 %
As (Arsenic): ≤ 0.0003 %
Ca (Calcium): ≤ 0.0200 %
Cu (Copper): ≤ 0.0025 %
Fe (Iron): ≤ 0.0020 %
Pb (Lead): ≤ 0.001 %
Zn (Zinc): ≤ 0.0025 %
Residual solvents (ICH Q3C): excluded by manufacturing process
Sulfated ash: ≤ 0.1 %
Loss on Drying (105 °C): ≤ 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

Safety & Documentation

Safety Information

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