Basic Info.
Model NO.
154598-52-4
Certification
GMP, ISO 9001, USP, BP
Suitable for
Elderly, Adult
State
Solid
Purity
>99%
Package
Aluminum Foil Bag
Delivery Detail
Prompt
Transport Package
as Per Your Requirement
Specification
GMP
Trademark
Mesochem
Origin
China
HS Code
2934999090
Production Capacity
500kg Per Month
Product Description
Certificate of Analysis
Product Name:efavirenz
CAS: 154598-52-4
Product Name:efavirenz
CAS: 154598-52-4
| Batch No. | HF160822 | Quantity | 1240kgs |
| Mfg. Date | Aug. 22, 2016 | Package | As required |
| Rep. Date | Aug. 25, 2016 | Exp. Date | Aug. 21, 2018 |
| Items | Standards | Results | |
| Appearance | White or off-white powder | Off-white powder | |
| Identification | By HPLC | Complies | |
| Melting Point | 120ºC~130ºC | 126ºC | |
| Loss on Drying | ≤1.00% | 0.21% | |
| Heavy Metals | ≤ 10ppm | Complies | |
| Sulfated Ash | ≤ 0.10% | 0.03% | |
| Content | 17.5%~19.5% | 19.3% | |
| Content | ≤ 0.1ppm | 0.09ppm | |
| Content | ≤ 3.0ppm | 0.50ppm | |
| Content | ≤ 0.1ppm | 0.10ppm | |
| Content | ≤ 0.1ppm | 0.10ppm | |
| Microbiological Test | Coliforms:Negative | Negative | |
| Salmonella: Negative | Complies | ||
| Total plate count: ≤1000 CFU/g | Pass | ||
| Yeast&Mold: ≤50 CFU/g | Pass | ||
| Related Substances | Impurity A: ≤0.30% | 0.18% | |
| Other unknown impurity: ≤0.10% | 0.07% | ||
| Total Impurities: ≤0.50% | 0.42% | ||
| Assay | ≥ 98.0% | 99.50% | |
| Reference Standard | USP Standard | ||
| Conclusion | The product complied to USP standard. | ||
| Storage | Preserve in tight,light-resistant containers in a cool place | ||
