Product Specification
1. General Specification
No. | Fields | Specification |
1.1 | Dosage form | Soft capsule |
1.2 | Shape | Oval |
1.3 | Physical appearance | Clear transparent shell containing light yellow liquid |
1.4 | Average fill weight | 1000mg |
1.5 | Average total weight | 1250mg |
1.6 | Uniformity of mass | ±7.5% |
1.7 | Disintegration | NMT. 30 minutes |
1.8 | Storage conditions | In a well closed container complied with food hygiene requirements, at 10 – 25°C and 35% - 65% R.H. |
1.9 | Shelf Life | 2 years from date of manufacture |
2. Master Formulation
No. | Active Ingredient | Actual input per capsule | Control method |
2.1 | Fish oil (50/20,EE) | 1000mg | QBI |
No. | Capsule shell | Actual input per capsule | Control method |
2.2 | Gelatin(Bovine skin) | 164mg | QBI |
2.3 | Glycerol | 65.5mg | QBI |
2.4 | Purified water | 20.5mg | QBI |
3. Microbiological Limits
No. | Item | Specification limit | Method |
3.1 | Total Aerobic Microbial Count (TAMC) | ≤ 1000CFU/g | GB 4789.2 |
3.2 | Total Yeast and Mould Count (TYMC) | ≤ 50 CFU/g | GB 4789.15 |
3.3 | Coli Form Group | ≤ 0.3 CFU/g | GB 4789.3 |
3.4 | Salmonella | Not detected/25g | GB 4789.4 |
4. Heavy Metals
No. | Item | Release limit | Method |
4.1 | Lead(Pb) | ≤ 3.0mg/kg | GB 5009.12 |
4.2 | Arsenic(As) | ≤. 1.0mg/kg | GB 5009.11 |
4.3 | Mercury(Hg) | ≤ 0.3mg/kg | GB 5009.17 |
(1) QBI: Quantity buy input.
Our plant is certified by ISO9001, ISO22000, FSSC22000 and Halal.
EU-NOVEL FOOD, FDA-GRAS or other certifications can be prepared according to requirement of new customers.
More product information about it will be supplied after your email requirement.