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SCM Pioneering Co.,Ltd
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Lomerizine hydrochloride was introduced as Teranas and Migsis in Japan for the treatment of migraine. It is the first in its class of dual sodium and calcium channel blockers to be marketed for this indication.In dogs, Lomerizine exerts a potent, selective and long-lasting vasodilation of cerebral arteries related to a combination of mechanisms, especially a functional block of L-type voltagesensitive calcium channels (L-VSCCs). Lomerizine increases cerebral blood flow compared to peripheral blood flow with only weak effects on systemic arterial blood pressure.
Product Name: High Quality Pitavastatin calcium Powder CAS 147526-32-7
CAS: 147526-32-7
MF: C25H26CaFNO4
MW: 463.56
EINECS:
Appearance: White Powder
Test Method: HPLC
Pitavastatin calcium is the calcium salt of pitavastatin. Used for treatment of hypercholesterolemia
(elevated levels of cholesterol in the blood) on patients unable to sufficiently lower their cholesterol levels
by diet and exercise. It has a role as an antioxidant. It is a calcium salt and a statin (synthetic).
Preserve in well-closed, light-resistant containers, and store in a refrigerator or freezer.
Pivastatin calcium is the first fully synthetic HMG-CoA reductase inhibitor jointly developed by Nissan Chemical
and Xingwa Co., LTD., a statin drug that reduces the liver's ability to produce cholesterol by inhibiting a liver
enzyme called HMGCo-A reductase, thereby improving elevated blood cholesterol levels. Mainly used to treat
patients with hypercholesterolemia and familial hypercholesterolemia, its lipid-lowering effect is very good, and
it is the most powerful lipid-lowering drug so far.
| Items |
Specification |
Result |
| Pitavastatin calcium |
98% |
98.5% |
| Organoleptic |
|
|
| Appearance |
white Powder |
Conforms |
| Color |
Brown yellow powder |
Conforms |
| Odor |
Characteristic |
Conforms |
| Taste |
Characteristic |
Conforms |
| Physical Characteristics |
|
|
| Particle Size |
NLT 100% Through 80 mesh |
Conforms |
| Loss on Drying |
<=12.0% |
Conforms |
| Ash (Sulphated Ash) |
<=0.5% |
Conforms |
| Total Heavy Metals |
≤10ppm |
Conforms |
| Microbiological Tests |
|
|
| Total Plate Count |
≤10000cfu/g |
Conforms |
| Total Yeast & Mold |
≤1000cfu/g |
Conforms |
| E.Coli |
Negative |
Negative |
| Salmonella |
Negative |
Negative |
| Staphylococcus |
Negative |
Negative |
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SCM Pioneering Co.,Ltd
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USP/EP Grade Pitavastatin Calcium Raw Material Powder
CAS 147526-32-7
Product Description
Pitavastatin calcium is the calcium salt of pitavastatin. Used for treatment of hypercholesterolemia(elevated levels of cholesterol in the blood) on patients unable to sufficiently lower their cholesterol levels by diet and exercise. It has a role as an antioxidant. It is a calcium salt and a statin (synthetic).
| Product name |
Pitavastatin calcium |
Appearance |
White powder |
| Standard |
USP/EP |
Solubility |
Water Soluble |
| Formula: |
C50H46CaF2N2O8 |
CAS: |
147526-32-7 |
| Tests |
Results |
Specifications |
| Character |
Complies |
White to almost white amorphous powder; odorless, tasteless; unstable to light, hygroscopic |
| Solubility |
Complies |
Should comply |
| Specific optical rotation |
+25° |
+20°~+26° |
| Specific absorbance |
960 |
960~980 |
Identification
|
Complies |
Chemistry reaction, should be positive reaction |
| Complies |
Chemistry reaction, should be positive reaction |
| Complies |
UV spectrophotometry, should comply |
| Complies |
By IR absorption, to match with the working standard |
| Complies |
Liquid chromatogram, should comply |
| Flu-orine |
4.1% |
4.0%~5.0%, calculated on the anhydrous basis |
Related substance
|
0.1% |
Epimer ≤ 0.5% |
| 0.03% |
Lactone compounds ≤ 0. 1% |
| 0. 1% |
Other single impurities ≤ 0. 1% |
| 0.4% |
The sum of impurities ≤ 1.0% |
| Enantiomer |
0.1% |
the area of the enantiomer is not more than 0.5 times the principal peak area
of the reference solution (0.5%). |
Residual solvent
|
0.05% |
Me-thanol ≤ 0.3% |
| 0 |
Ethanol ≤ 0.5% |
| 0 |
Dichloro me-thane ≤ 0.06% |
| 0 |
Tetrahy drofuran ≤ 0.072% |
| 0 |
Tolu ene ≤ 0.089% |
| Chloride |
Complies |
≤ 0.06% |
Microbial limit
|
< 10 cfu/g |
Bacterial count: NMT 80 cfu/g |
| < 10 cfu/g |
Fungus and yeast count: NMT 10 cfu/g |
| Absent |
Escherichia coli: Absent |
| Calcium |
4.1% |
4.0%~5.0%, calculated on the anhydrous basis |
| Water |
2.1% |
≤ 3.0% |
| Heavy metals |
Complies |
≤ 20ppm |
| Assay(calculated on the dried basis) |
100.2% |
≥ 98.5%(C50H46GaF2N2O8) |
Application
Pivastatin calcium is mainly used to reduce cholesterol and low-density lipoprotein. It is one of the statins that regulate blood lipid. It acts as a rate limiting enzyme in the cholesterol synthesis pathway to reduce the synthesis of cholesterol.
It is often used in the prevention of ischemic cardio cerebrovascular diseases. It can also stabilize atherosclerotic plaque and avoid the occurrence of acute ischemic cardio cerebrovascular events caused by plaque rupture.
Packaging & Shipping
Company Profile
SCM Pioneering Co., Ltd
The professional supplier of food ingredients & additives, SCM Pioneering Co., Ltd is an emerging growth enterprise located in China (Shandong) Pilot Free Trade Zone.
The company was established by a group of experts who have more than twenty years of industry-related experiences, and committed to the development of products that are beneficial to human health and safety.
With our deep knowledge and diligence, together with our associated factories, we would like to provide one-stop sourcing solutions for customers, to save your time and secure your purchasing.
Base everything and anything upon customers' interests and provide quality and value-added services from the date of establishment, SCM Pioneering has a rapid development, with customers in over 25 Countries until 2022, and a variety of high quality food ingredients, like Sweeteners Sucralose, Neotame, Stevia extract, Erythritol, Monk fruit extract, and Nutrition enhancers like Creatine monohydrate, Alpha Lipoic Acid, Coenzyme Q10, L-Glutathione, PQQ.
Thanks for all you concern and support, which is very very precious in our eyes. For any interest in products, services,
information, or cooperation, please feel free to contact us.
we are faithfully looking forward to cooperating with you!
 
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Pharma Sources Insight June 2024: Globalization on the Go
