| مشخصات فنی محصول | |
|---|---|
| Assay (Perchloric acid titration*) | 50.0 - 51.0 % |
| Assay (Stereochemical purity of sodium(S)-lactate) | ≥ 95.0 % |
| Identity (Sodium) | passes test |
| Identity (Lactat) | passes test |
| Appearance of solution | Clear and not more intense in color than reference solution BY₇ |
| pH (for the substance to be examined) | 6.5 - 9.0 |
| Chlorid (Cl)* | ≤ 50 ppm |
| Sulfate (SO₄) (Ph. Eur.*) | ≤ 100 ppm |
| Sulphate (SO₄) (USP) | passes test |
| Heavy metals (as Pb)* | ≤ 10 ppm |
| Al (Aluminium) | ≤ 0.1 ppm |
| As (Arsenic)* | ≤ 3 ppm |
| Ba (Barium) | passes test |
| Fe (Iron)* | ≤ 10 ppm |
| Hg (Mercury) | ≤ 1 ppm |
| Pb (Lead) | ≤ 5 ppm |
| Oxalate and Phosphate (Ph. Eur.) | passes test |
| Citrate, Oxalate, Phosphate or Tartrate (USP) | passes test |
| Methanol and Methyl Esters | ≤ 250 ppm |
| Reducing sugars and saccharose (Ph. Eur.) | passes test |
| Sugar (USP) | passes test |
| Methanol* | ≤ 50 ppm |
| Residual solvents (ICH Q3C) | excluded by manufacturing process |
| Total aerobic microbial count (TAMC) | ≤ 100 CFU/ml |
| Total combined yeasts/moulds count (TYMC) | ≤ 10 CFU/ml |
| Bile-tolerant gram-negative bacteria (absent in 1 ml) | passes test |
| Candida albicans (absent in 1 ml) | passes test |
| Escherichia coli (absent in 1 ml) | passes test |
| Pseudomonas aeruginosa (absent in 1 ml) | passes test |
| Salmonella (absent in 10 ml) | passes test |
| Staphylococcus aureus (absent in 1 ml) | passes test |
| Endotoxins | < 5 |
| *calculated on sodium lactate Residues of metal catalysts or metal reagents acc. to EMEA/CHMP/SWP/4446/2000 are not likely to be present. |
|
| Corresponds to Ph. Eur., BP, USP | |
جدول ویژگیهای کلیدی محصول
| گریدهای مرتبط |
|---|
| Ph Eur,BP,USP |
| شرح محصول | |
|---|---|
| Catalogue Number | 106522 |
| اطلاعات محصول | |
|---|---|
| Grade | Ph Eur,BP,USP |
| HS Code | 2918 11 00 |
| Structure formula Image | |
| اطلاعات فیزیکی و شیمیایی محصول | |
|---|---|
| Boiling point | 109 °C (1013 hPa) |
| Density | 1.263 g/cm3 (20 °C) |
| pH value | 6.5 - 9.0 (H₂O) |
| اطلاعات ایمنی بر اساس GHS | |
|---|---|
| Storage class | 10 - 13 Other liquids and solids |
| WGK | WGK 1 slightly water endangering |
| Disposal | 3 Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C. |
| اطلاعات بارگیری و نگهداری | |
|---|---|
| Storage | Store at +5°C to +30°C. |
| اطلاعات حمل و نقل | |
|---|---|
| Declaration (railroad and road) ADR, RID | Kein Gefahrgut |
| Declaration (transport by air) IATA-DGR | No Dangerous Good |
| Declaration (transport by sea) IMDG-Code | No Dangerous Good |
 |
||||
|
