| CAS No.: | 12650-88-3 |
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| Environmental Protection: | Yes |
| Certification: | ISO |
| Color: | White Powder |
| Classification: | Pharmaceutical Ingredients |
| Function: | Pharmaceutical Ingredients |
| Samples: |
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| Customization: |
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Product Name:Lysozyme
Specification:Lysozyme activity NLT 10000Units FIP/mg
Appearance: White powder
| TECHNICAL DATE SHEET | ||
| PRODUCT SPECIFICATIONS | ||
| Product Name: | Lysozyme | |
| Internal Code: | 000-00756 | |
| Source: | Hen Egg white | |
| Country of Origin: | China | |
| ANALYSIS ITEMS | SPECIFICATION | TEST METHOD |
| Appearance | Fine powder | Organoleptic |
| Color | White | Visual |
| Odour & Taste | Characteristic | Organoleptic |
| Identification | Identical to R.S. sample | HPTLC |
| Lysozyme activity | NLT 10000Units FIP/mg | |
| Purity | NLT 99.0% | |
| Solubility | Almost soluble in water | |
| Hydrocarbons PAHs | ≤ 50 ppb -Reg.UE 1933/2015 | GC-MS |
| Benzo(a)pyren | ≤ 10 ppb -Reg.UE 1933/2015 | GC-MS |
| Radioactivity | ≤ 600 Bq/Kg -Reg. CE 1409/2009 | |
| Apparent density | 0.4-0.7g/ml | |
| Sieve Analysis | 100% through 80 mesh | USP39 <786> |
| Loss on drying | ≤ 6.0% | Eur.Ph.9.0 [2.5.12] |
| Total Ash | ≤ 2.0% | Eur.Ph.9.0 [2.4.16] |
| Lead (Pb) | ≤ 5.0 mg/kg | Eur.Ph.9.0<2.2.58>ICP-MS |
| Arsenic (As) | ≤ 1.0 mg/kg | Eur.Ph.9.0<2.2.58>ICP-MS |
| Mercury(Hg) | ≤ 1.0 mg/kg | Eur.Ph.9.0<2.2.58>ICP-MS |
| Heavy metal | ≤ 10.0 mg/kg | Eur.Ph.9.0 <2.4.8> |
| Aerobic bacteria(TAMC) | ≤1000 cfu/g | USP39 <61> |
| Yeast/Moulds(TAMC) | ≤100 cfu/g | USP39 <61> |
| Bile-tol.gram- b./Enterobact.: | ≤100 cfu/g | |
| Escherichia coli: | Absent in 1g | USP39 <62> |
| Salmonella: | Absent in 25g | USP39 <62> |
| Staphylococcus aureus: | Absent in 1g | |
| Aflatoxins B1 | ≤ 5 ppb -Reg.EC 1881/2006 | USP39 <62> |
| Aflatoxins ∑ B1, B2, G1, G2 | ≤ 10 ppb -Reg.EC 1881/2006 | USP39 <62> |
| Irradiation | No Irradiation | |
| GMO | Product No-GMO (Reg.1829/2003-1830/2003 EC) | |
| Allergens | Not allergen free/Egg present | |
| BSE/TSE | Free. | |
| Melamine | Free, No melamine(Reg.EU 594/2012) | |
| Ethylen-oxide | No Ethylen-oixde | |
| Vegan | Not suit for vegan | |
| Packing | Pack in paper-drums and two plastic-bags inside N.W. 25 kgs I.D.35xH51cm. | |
| Storage | Store in a well-closed container away from moisture, light, oxygen. | |
| Shelf Life | 24 months under the conditions above and in its original packaging | |
1.As a natural preservative, Lysozyme has many unique advantagesstrong anti-bacterial, safe, good thermal stability, wide role range etc.
2.Lysozyme is a protein, is relatively stable as the pH changes, thermal stable under acidic conditions.By using bio-engineering techniques, regulating protein PH value and adsorption isolated by ion exchange resin we can get fine fine enzyme of which enzyme activity can be more than 18 000 u / g while meeting the pharm grade.
3.Lysozyme can dissolve bacterial cells, especially has a stronger role against Gram-positive bacteria while has the nature of antibiotics.
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