Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Items | Specifications | Result | |
Appearance | White to pale yellow powder | White powder | |
Solubility | Practically insoluble in water, very soluble in ethanol, slightly soluble in hexane | Conforms | |
Appearance of Solution (EP Method) | Solution is clear, color≤GY5 | Conforms | |
Identification A(IR) | IR spectrum corresponds to the IR spectrum of the reference standard | Conforms | |
Identification B(HPLC) | The retention time of the major peak of sample solution corresponds to that of the standard solution. | Conforms | |
Organic Impurities | Early-Eluting Impurities | Moxidectin butenyl analoga (RRT=0.5) ≤1.5% | 0.78% |
5-Demethyl moxidectinb (RRT=0.7) ≤0.5% | 0.24% | ||
Moxidectin pentenyl analogc (RRT=0.75) ≤1.5% | 0.71% | ||
Moxidectin 17a-epimerd (RRT=0.9) ≤2.5% | 1.09% | ||
Impurity(23Z)(RRT=1.2) ≤0.5% | 0.05% | ||
Sum of moxidectin 19-s-17a-enee and moxidectin ethyl isomersf (RRT=1.3-1.5) ≤1.7% | 1.14% | ||
Milbemycin B analog(moxidectin open ring)g(RRT=1.6) ≤1.5% | 0.06% | ||
Any other individual impurity before Milbemycin B analog(Moxidectin open ring)g≤0.5% | 0.11% | ||
Late-Eluting Impurities | Moxidectin deoxydienea and 4,-Methylthinmethyoxymoxidectinb(RRT=2.0) ≤1.0% | 0.06% | |
20b-Methylthiomoxidectinc (RRT=2.2) ≤0.5% | 0.02% | ||
20-Nitrobenzoylmoxidectind (RRT=3.4) ≤0.5% | 0.03% | ||
Any other individual impurity after the milbemycin B analog(moxidectin open ring) (RRT≈1.4) ≤0.5% | 0.01% | ||
Total Organic Impurities | ≤7.0% | 4.42% | |
Residue on Ignition | ≤0.2% | 0.02% | |
Heavy Metals | ≤1.3% | 0.65% | |
Moxidectin Assay (As is) | ≥90% | 92.4% | |
Moxidectin Assay (On the anhydrous basis) | 92.0%~102.0% | 93.1% | |
Antioxidant Assay (BHT)(In-house) | 0.3%~0.6% | 0.43% | |
Accountability | ≥95% | 97.9% | |
Residual Solvents (In-house) | Methanol≤3000ppm | Absent | |
Ethanol≤5000ppm | Absent | ||
Dichloromethane≤600ppm | Absent | ||
Propenol≤50ppm | Absent | ||
Triethylamine≤320ppm | Absent | ||
N-Heptane≤5000ppm | Absent | ||
Methylcyclohexane≤1180ppm | Absent | ||
1,4-Dioxane≤380ppm | Absent | ||
Butyl Acetate≤5000ppm | Absent | ||
Dimethyl Sulfoxide≤5000ppm | 21ppm | ||
Total Residual Solvents≤5000ppm | 21ppm | ||
Bacterial Endotoxins | ≤0.1EU/mg | <0.1EU/mg | |
Bioburdern | ≤300CFU/g | Conforms | |
Conclusion | It meets the requirements of USP40 |
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.