Nitrendipine powder
CAS.NO:39562-70-4
structural formula:C18H20N2O6
EINECS.no:254-513-1
Other names:Nitrendipine;Nitrendipin;Bylotensin;baypress
Test Method:HPLC/UV/GC-MS
MOQ & Package: 10g,100g,1kg,5kg,10kg,25kg etc
Customer's rights and interests:Over 10kg, you can enjoy the service of giving away free samples.
Certificate：FDA,ISO,COA, HPLC, MSDS,TDS etc
Lead Time: 1-3 days
Shipping: DHL,Germany DHL,Germany DPD,UPS,USPS,FedEx,EMS,By Air,By Sea,multimodal transport etc
Store & Shelf life; Cool & dry place; 36 months
Company advantages: there are self-built overseas warehouses and third-party overseas warehouses on all continents.
- Product Description
Xi'an Faithful BioTech Co., Ltd: Your Trusted Nitrendipine powder Manufacturer & Supplier
Nitrendipine Powder is a second-generation calcium channel blocker recognized as an ideal pharmaceutical raw material for the treatment of hypertension. It exhibits significant and sustained antihypertensive and vasodilatory effects. The product is suitable for various types of hypertension, including primary and secondary mild to moderate hypertension, and can also be used in the management of coronary heart disease and congestive heart failure. The API nitrendipine produced by Xi'an Faithful BioTech Co., Ltd Company is extracted from the natural derivative of nitrendipine acid, offering higher yield and a more environmentally friendly profile compared to traditional synthetic methods.
Nitrendipine powder Introduction
Nitrendipine powder is a calcium channel blocker that can counteract the entry of calcium ions into cells, causing vascular smooth muscle relaxation and reducing blood pressure and myocardial oxygen consumption. It has a selective effect on L-type calcium channels, mainly acting on the heart and blood vessels. It has the characteristics of long duration of action, low occurrence of rebound phenomenon, and no impact on heart rate. In the clinical treatment of hypertension and angina, it is not significantly affected by food. Widely metabolized in the liver as glucuronic acid conjugates and other metabolites, highly bound to plasma proteins (approximately 95%). The half-life is about 6-9 hours.
Specifications
Item | Specifications | Results |
Appearance | Yellow crystalline or crystalline powder | Conforms |
Mesh | 98% pass 100mesh | Conforms |
pH | 5.0-8.0 pH(1% aqua） | Conforms |
Purity | ≥98.00% | 98.88% |
Loss on drying | ≤5.0% | 2.52% |
Loss on ignition | ≤5.0% | 2.18% |
Heavy metals (as Pb) | ≤20mg/kg | ＜20mg/kg |
As | ≤2.0mg/kg | ＜2.0mg/kg |
Total Plate Count | <10000cfu/g | 2208cfu/g |
Yeast and Mould | <100cfu/g | <10cfu/g |
E.Coli | Negative | Negative |
Salmonella | None detected in 10g | Negative |
| Conclusion | Conform with enterprise specification （USP 41）. |
Why Choose Us?
We chose our nitrendipine powder because we use a green and environmentally friendly process extracted from natural product nitrendipine acid, which has higher yield and less waste compared to traditional synthesis methods, and is more in line with sustainable development requirements.
Our product has a purity of over 99% and meets international pharmacopoeia standards such as CP, USP, and EP. Impurities are strictly controlled at industry-leading levels to ensure the quality stability of the formulation production.
We offer competitive prices, a comprehensive supply system, and professional technical support to provide customers with cost-effective raw materials and customized solutions to meet diverse production needs.
please leave a message via email: sales8@faithfulbio.com ,Welcome to the store for inquiries.
What are its pharmacokinetic characteristics?
According to on-site statistics, it is well absorbed in the human body, but there is a significant first pass effect, with a bioavailability of about 10-20%. The protein binding rate is about 98%, and the distribution volume is about 6L/kg. Mainly metabolized in the liver, it is metabolized into inactive metabolites by the CYP3A4 enzyme system and excreted by the kidneys. The elimination half-life is 2-4 hours.
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FAQ
Q1. What are its quality standards??
The quality standards for the raw material of nitrendipine require a content of ≥ 99.0%, related substances ≤ 1.0%, drying loss ≤ 0.5%, ignition residue ≤ 0.1%, and heavy metals ≤ 10ppm. The product appears as a yellow crystalline powder, odorless, tasteless, and easily soluble in acetone or chloroform. Must comply with international pharmacopoeial standards such as CP, USP, EP, etc.
Q2. How to detect the content and related substances of Nitrendipine powder?
High performance liquid chromatography (HPLC) was used for detection. Chromatographic conditions: C18 column, methanol water (70:30) as mobile phase, detection wavelength of 235nm. This method has good specificity and high accuracy, and can simultaneously determine the content and related substances.
Q3. What are the main synthesis methods for it??
The synthesis of nitrendipine mainly adopts the Hantzsch synthesis method, using m-nitrobenzaldehyde, methyl acetoacetate, and methyl 3-aminocrotonate as raw materials, and conducting cyclization reaction in the presence of a catalyst. This process route is mature, with a yield of over 60%, suitable for industrial production.
Q4. What are its storage conditions?
It should be stored in a dark, sealed place, in a cool and dry place, away from direct sunlight and humid environments. It is recommended to store between 15 ° C and 30 ° C. It should be stored out of reach of children and avoid mixing with other drugs and food.
Q5.How long is its validity period?
The expiration date of nitrendipine raw materials is usually 24-36 months, depending on the expiration date label on the drug packaging. Expired drugs should not be continued to be used.
Contact us
Nitrendipine, as a classic blood pressure lowering ingredient, still has a certain market share globally. Our company can provide Nitrendipine powder and similar products. If you have any relevant procurement plans, please leave a message:sales8@faithfulbio.com.
