| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
|
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| Items | Requirements | Result |
| Appearance | White or almost white crystalline powder | White crystalline powder |
| Solubility | Soluble in acetone; soluble in methanol practically insoluble in water. | Conform |
| Identification |
Infrared Absorption: The infrared absorption spectrum of the sample corresponds to that of the reference substance. | Conform |
| HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay. | Conform | |
| Optical ration, specific rotation | -39°to -41° | -40.1° |
| Water determination, method | 5.0%~7.0% | 5.6% |
| Residue on Ignition | ≤0.1% | 0.05% |
| Heavy metals | ≤20ppm | Conform |
| Residual solvents | Pyridine≤200ppm | Not detected |
| Dichloromethane≤600ppm | Not detected | |
| Hexane≤290ppm | Not detected | |
| Toluene≤890ppm | Not detected | |
| Ethyl acetate≤5000ppm | Not detected | |
| Acetone≤5000ppm | 149ppm | |
| Methanol≤3000ppm | Not detected | |
| Acetic acid≤5000ppm | Not detected | |
| Organic Impurities (Procedurel) |
10-Deacetyl baccatin≤0.15% | Not detected |
| 2-Debenzoxyl 2-pentenoyl docetaxel≤0.5% | 0.03% | |
| 6-Oxodocetaxel≤0.3% | 0.02% | |
| 4-Epidocetaxel≤0.3% | 0.06% | |
| 4-Epi-6-oxodocetaxel≤0.2% | 0.02% | |
| 6-Dichloroethoxy-carbonyl docetaxel≤0.15% | Not detected | |
| N-Formyl impurity≤0.15% | Not detected | |
| Any unspecified impurity≤0.10% | 0.016% | |
| Total impurities≤1.0% | 0.15% | |
| Microbial Enumeration Test | Total aerobic microbial≤100 cfu/g | <10cfu/g |
| Total molds and yeasts≤10 cfu/g | <10cfu/g | |
| Tests for specified Microorganisms | Staphylococcus aureus: Absence | Absence |
| Pseudomonas aeruginosa: Absence | Absence | |
| Salmonella typhimurium: Absence | Absence | |
| Escherichia coli: Absence | Absence | |
| Bacterial Endotoxins | ≤0.4 EU/mg | Conform |
| Assay (anhydrous substance and solvent-free) | 97.5% to 102.0% | 99.2% |
| Conclusion | Conform to the Standards. | |
Novcare Pharmaceutical is a global trading and Contract manufacturing company specializing in APIs, Pharmaceutical Intermediates, Neutraceuticals, Specialty Chemicals, R&D and Agro Chemicals. we proudly offer a portfolio of internationally recognized products. A combination of Professional leadership, exemplary market knowledge and unrelenting commitment to quality has been instrumental in making Novcare a well-respected name in the business.
At Novcare, we focus on becoming a Value-Added Support Partner for all of our clients by delivering solutions that are high on quality, cost-effective, and timely. Our team of professionals possess extensive industry and government experience in international trade law and are well-acquainted with market trends and in tune with the latest market developments. With our insightful market intelligence and analysis, we're able to identify authentic sources for hard to find and urgently needed products, a crucial element in the pharma and biotechnology sector.
We stick to the principle of "Customer First, Qaulity foremost".
CUSTOMER SERVICE:
Quick and clear response to customers questions. Warm after sale service, we will help to solve the problems in your usage.
TRANSPORTATION:
We can send the goods to your delivery address directly.It is relatively safe and fast. We have ready goods in stock.
PACKAGE:
It can be packaged according to customer requirements or product characteristics to better protect product safety.
PRICE:
The customer comes first, we provide reasonable price, high quality product and prompt shipment.
Q: What's your MOQ ?
A: For the high value product, our MOQ starts from 1g and generally starts from 10gs. For other low, price product, our MOQ starts from 100g and 1kg.
Q: Is there a discount ?
A: Yes, for larger quantity, we always support with better price.
Q: How to confirm the Product Quality before placing orders ?
A: You can get free samples for some proucts, you only need to pay the shipping cost or arrange a courier to us and take the samples. You can send us your product specifications and requests, we will manufacture the products according to your requests.
Q: How to start orders or make payments ?
A: You can send our your Purchase order ( if your company has ), or just send a simple confirmation by email or by Trade Manager, and we will send you Proforma Invoice with our bank details for your confirmation, then you can make payment accordingly.
Q: How do you treat quality complaint ?
A: First of all, our quality control will reduce the quality problem to near zero. If there is a quality problem caused by us, we will send you free goods for replacement or refund your loss.
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