Pharmaceutical Raw Materials

About the company:

The supplier is a private enterprise with major of employees as researchers and producers of pharmaceutical chemistry and organic biochemistry.

The production body is making medicine of natural valuable medicinal herbs. Quality control is done in laboratories with modern testing equipment. All products have received quality certificates.

The trade body is mainly responsible for trading of products mentioned above. The body is constituted with specialist having a good knowledge of natural medical materials, processing technology, commercial products and markets of pharmaceutical materials and medicines.

Following products are available:

1. Rutin (C₂₇H₃₀O₁₆3H₂O):

Rutin is a medicinal herb being extracted from Sophora Japonica, used for producing drug of high blood pressure treatment, vessel wall protection, internal organs bleeding. The product with Rutin content of 95% is satisfactory to NF-XI Pharmacopoeia Standard (American Standard), the German DAB-VIII Standard and the Japanese JP-VIII Standard.

The product is in form of pure yellow flour.

2. Artemisinin C₁₅H₂₂O₅ (included Dihydro Artemisinin, Artesunate and Artemethel):

used for producing antimalarial. Artemisine is extracted from the Artemisia Annua L leaves. The Artemisine content is 99%, the Artesunate content is 98%.

3. Rotundine (C₂₁H₂₅NO₄)

Rotundine with content of more than 98% is extracted from Stephania Rotundine Menispermaceae, a natural medicinal herb. Rotundine is used for producing tranquilliser with safe sleeping effect and without side-effects.

Pharmaceutical Raw Materials - Detailed Description

Test Report
(Technical Specification)
No: 35-KN

Sample tested: Powder RUTIN
Status: Tested as request
Sample: Produced at manufacturing workshop
Testing method: Ultraviolet

Test result:

Test target	Actually tested result
1. Essence	Correct
2. Loss on drying: 5.5%-9.0%	7.2%
3. Ash: <0.5%	Comply
4. Chlorophyl: <0.004%	Comply
5. Red pigment: 0.004%	Comply
6. Quercetin: <5%	< 2%
7. Content: 95%~101.5% (after drying)	95.6%

Rutin - Chemical structure

Molecular formular: C₂₇H₃₀O₁₆3H₂O
Mol.wt. 664.59
m.p. 185-192 °C
Purity ≥ 95%
Loss on drying: 5.5%-9.0%
Quercetin: not more than 5%
Chlorophyll and Red Pigment: each contains no more than 0.004%

Rutin is the 3-rhamnoglucoside of 5.7.3`.4` tetrahydroxy flavonol obtained from unopened flower buds of Sophora Japonica L.

Rutin is useful for treating certain hemorrhagic disorders. It also has "Vitamin P" properties, found that it was effective in treating patients with hypertension complicated by increased capillary fragility, particularly when combined with ascorbic acid.

Outside, they reported that it has good anti-oxydant properties, can be used in foodstuff industry.

Artemisinin - Chemical structure

Molecular formula: C15H22O5
m.p.: 151-153 °C
[α]₂₀^D - 63° (0.48CHCl₃)
Purity: 99%

Artemisinin is the antimalarial principle isolated from the wormwood (Artemsisia Annua L), a traditional Vietnamese and Chinese herb of the family Compositae. It has shown to have marked activity against malaria parasites including multi-drug resistant isolates "Plasmodium Falciparum".

With its new structure and new mode of action, Artemisinin is considered as the most promising candidate for the treatment of malaria and the patient of a new class of antimalarial drugs.

Testing Bill

Sample to be tested: Artemisinin Material

Requirements	Results
1. Nature: must be satisfactory	Passed
2. Qualitative: Reaction of Artemisinin is required	Right
3. Melting point: not less than 152°C	Passed (154°C)
4. Pole rotation capacity:\| α \|25D= 64-66 °C	Passed (65.7°C)
5. Purification density
- Volume loss during drying: Not over 0.5%	Passed (0.2%)
- Arsemic: Not over 0.0002%	Passed
- Sulfat Ash: Not over 0.1%	Passed (unremarkable)
- Heavy metal: Not over 0.001%	Passed
- Clearness and color of the solution: To be subject to stipulation	Passed
- Extraneous matters: To be subject to stipulation	Passed
6. Quantity: Artemisinin content is at least 98.5% in form of dried product	Passed (98.9%)

Certificate of Analysis

Name of product: Artesunate

No	Specification	Results
1	Characteristic: white crystalline powder; odorless	complies
2	Specification optical rotation: xD24o=-10_+14	complies
3	Identification: - The infrared absoption spectrum is concordant with the spectrum reference substance - Thin – layer Chromatography: Must be concordant with the reference substance - Two reactions of Artesunate must be contained	complies complies complies
4	Water: Not more than 0.5%	complies
5	Sulfated ash: Not more than 0.1%	complies
6	Chloride: Not more than 0.02%	complies
7	Acid: pH of solution 15 : 3.5 – 5.0	complies
8	Heavy metal: Not more than 0.001%	complies
9	Related substance: Test as required	complies
10	Assay: It contains not less than 98% and not more than 102% of C19H28O8, calculated with reference to the anhydrous substance	complies

Testing Bill

Sample to be tested: ROTUNDIN

Requirements	Results
1. Nature: To be satisfactory	Passed
2. Melting Point: Melted within 141°C to 144°C	Passed
3. Specific absorption: Tested as per standard. Specific absorption is 150 to 160	Passed (154)
4. Qualitative: The product has to show Rotundin's qualitative reactions	Right
5. Purity and color of the solution: To be satisfactory	Passed
6. Other alcaloid: Subject to limits of other alcaloid	Passed
7. Humidity: Not over 5%	Passed (4.3%)
8. Specific pole rotation angle: Solution 8mg/ml in ethanol, tested at 25°C, has specific pole rotation angle within 290° to 300°	Passed (-296°)
9. Percentage after burning: Not over 10%	Passed (0.04%)
10. Quantitative: Content of Rotundin C21H25NO4 in the product is not less than 98% in form of dried product	Passed (99.6%)

L.TETRAHYDROPALMATINE - Chemical structure

Molecular formular: C₂₁H₂₅NO₄
Mol.wt. 355,42
m.p. 140°C -143°C
Purity ≥ 98%
Residue on ignition: < 1%

L-Tetrahydropalmatine is the 5,8,13,13a–Tetrahydro–2,3,9,10–tetramethoxy–6H-dibenzo [a,g] quinolizine obtained from Stephania Rotunda belonging to menispermaceae family.

L-Tetrahydropalmatine is used for treatment of losing sleep, decreasing blood pressure and also used as a tranquilizer.

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