Yunnan Yunhe Pharmaceutical Co., Ltd.
Issuing department: Quality Control Test no.: R-QC-013-02
Date issued: 10/28/06 Date reported: 11/1/06
|
Product name |
Dragon’s Blood capsules |
Specifications |
0.3g x 120 caps/bottle |
|
Lot no. |
061022 |
Test report no. |
06030 |
|
Lot quantity |
305 bottles |
Issuing department |
Oral solid preparation workshop |
|
Package |
Plastic bottles |
Test reference |
WS3-B-2541-2001 |
Test item Standard Test result Test conclusion
(Shape/form) Gelatin capsule filled with reddish brown to conforms to standards
dark brown powder. The product has a distinct
odor that is slightly aromatic. The flavor is bland
and slightly astringent. When chewed/eaten it
produces a charcoal grain-like feeling that
slightly sticks to the teeth.
(test results are same)
(Differentiation) 1.) The chromatography of the test product
when compared with Cochinchinenin in
corresponding positions revealed the same color
flecks.
Conforms Conforms
2.) In the chromatography of the test product
when compared with the raw material,
corresponding positions revealed the same color flecks.
Conforms Conforms
(Inspection)
Absorption must not be below 0.40 0.462 Conforms
Matter insoluble
In alcohol matter that is insoluble 0.43% Conforms
in ethanol must not exceed 1.5%
page 1 of 2
Scorched residue must not exceed 0.7% 0.59% Conforms
Heavy metals must not exceed 15 PPM didn
’t exceed ConformsMoisture must not exceed 9.0% 1.68% Conforms
Packaging disparity 0.3g/capsule (1+/-10%) Conforms Conforms
Disintegration time 30 minutes to complete
disintegration. 28 minutes Conforms
Arsenic must not exceed 2mg/kg 0.12mg/kg Conforms
Lead must not exceed 5mg/kg 0.22mg/kg Conforms
Cadmium must not exceed 0.3mg/kg <0.05mg/kg Conforms
Mercury must not exceed 0.2mg/kg <0.01mg/kg Conforms
Microbiological
Limits
Standard plate count must not exceed 1000 CFU/g 10 CFU/g Conforms
Mold/yeast must not exceed 100 CFU/g 10 CFU/g Conforms
E. Coli must be undetectable none detected Conforms
P. aeruginosa must be undetectable none detected Conforms
Staphyloccus aureus must be undetectable none detected Conforms
Insect fragments must be undetectable none detected Conforms
(Content measure)
every capsule containing
Dragon’s Blood as well as Loureirin B
must not be below 1.20 mg
1.97mg/capsule Conforms
Conclusion: This product, based on the results from test reference # WS
3-B-2541-2001, conforms to all applicable standards.Supervisor:
Cross check personnel:
Test personnel: