MERCK 100590.1000 Glycine cryst. suitable for EMPROVE CAS No. 56-40-6
| Specifications |
|---|
| Assay (perchloric acid titration, calculated on dried substance) | 99.0 - 101.0 % |
| Identity (IR-spectrum) | passes test |
| Identity (TLC) | passes test |
| Appearance | white to almost white, crystalline powder |
| Appearance of solution (100 g/l, CO₂-free water) | clear and colorless and not more intense in color than reference solution Y₇ |
| Acidity (50g/l, water) | 5.6 - 6.6 |
| pH (50 g/l CO₂-free water) | 5.9 - 6.4 |
| Transmittance of solution (50 g/l, water) | ≥ 98.0 % |
| Chloride (Cl) | ≤ 70 ppm |
| Sulfate (SO₄) | ≤ 60 ppm |
| Fe (Iron) | ≤ 10 ppm |
| Heavy metals (as Pb) | ≤ 10 ppm |
| As (Arsenic) | ≤ 1 ppm |
| Hydrolyzable substances | passes test |
| Related substances (TLC) | passes test |
| Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) | ≤ 0.10 % |
| Ninhydrin-positive substances (LC) (ammonium (570 nm)) | ≤ 0.02 % |
| Ninhydrin-positive substances (LC) (total impurities) | ≤ 1.0 % |
| Related substances (HPLC) (Impurity B) | ≤ 0.10 % |
| Related substances (HPLC) (Impurity H) | ≤ 0.10 % |
| Related substances (HPLC) (Impurity I) | ≤ 0.10 % |
| Related substances (HPLC) (unspecified impurities) | ≤ 0.10 % |
| Sum of impurities (Ph Eur) | ≤ 0.2 % |
| Related compounds (HPLC) (Glycine anhydride) | ≤ 0.10 % |
| Related compounds (HPLC) (Iminodiacetic acid) | ≤ 0.10 % |
| Related compounds (HPLC) (Diglycine) | ≤ 0.10 % |
| Related compounds (HPLC) (Triglycine) | ≤ 0.10 % |
| Related compounds (HPLC) (Hexamethylenetetramine) | ≤ 0.10 % |
| Sum of impurities (USP) | ≤ 1.0 % |
| Methanol (HS-GC) | ≤ 3000 ppm |
| Other residual solvents (ICH Q3C) | excluded by manufacturing process |
| Loss on drying (105 °C, 2 h) | ≤ 0.2 % |
| Sulfated ash (600 °C) | ≤ 0.1 % |
| Bacterial endotoxins | ≤ 2.0 I.U./g |
| Total aerobic microbial count (TAMC) | ≤ 10 CFU/g |
| Total combined yeasts/moulds count (TYMC) | ≤ 10 CFU/g |
| 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, ChP, JP, USP |
