1.Size:000#,00#,...5#
2.Empty gelatin capsule
3.Empty HPMC capsule
4.Empty 100% bone glue capsule
5.Good quality and service
The capsule 000 sizes are belows:
* Weight (mg) = 163±10
* Capacity (ml): 1.7
* Length: 22.20mm body / 12.95mm cap
* Diameter (mm): body: 9.55 / cap: 9.91
* Closed length (mm): 26.1±0.3
HENAN BOOM GELATIN CO., LTD
NO.96, MIDDLE OF HANGHAI ROAD, ZHENGZHOU, HENAN, CHINA
CERTIFICATE OF ANALYSIS
Product Name | Empty capsule | Size and color | 000# (Green/ White) |
Batch Number | 20100707 | Packaging | Models the bag |
Quantity | 500,000pcs | Sample date | Jul.21.2010 |
Send samples departments | Workshop | Reports the date | Jul.28.2010 |
Sample drawn | 100g | Inspection project | All examines |
Inspection basis | <Chinese Pharmacopoeia> in 2000 edition second |
Test Items | Standard regulation | Results | ||
Property | Elastic 2-pieces empty hard gelatin capsules, consists of cap and body of lustrous surface, even color, trim kerf, no distortion, no odor. Classified into three kinds as transparent, semi-transparent and opaque. | It is green vacant capsule. Conform to the stipulation | ||
Identification | Shall be positive | Conform | ||
Elastic tightness | Shall conform to standard | Conform | ||
Friability | Shall conform to standard | Conform | ||
Pine Tight Degree | Leaks the powder not to have 2 grains | Conforms to the stipulation | ||
Time of disintegration | Does not have 10 minutes
| 9 minutes (add baffle) | ||
Dry weightlessness | Should be 12.5%-17.5% | 15.1% | ||
Residue on ignition | transparent | ≤2% | 2.1% | |
Semi-transparent | ≤3% | |||
opaque | ≤5% | |||
Heavy metal | ≤50ppm | Conform | ||
Viscosity | Does not have to be lower than 60mm2/s | 80.5 | ||
Sulfite | Does not have 0.02% | Conform | ||
Microorganism limit | Total coun of bacteria(/g) | <1000 | Conform | |
Total coun of mildew(/g) | <100 | Conform | ||
Escherichia coli | Should to not be detected | Not detected | ||
Conclusion | The product according to "Chinese Pharmacopoeia" in the 2000 edition second. The examination result conforms to the stipulation | |||
Analyst: Xiaodan Cui QCManager: Xiaohui Zheng