| Customization: | Available |
|---|---|
| Certification: | ISO, Kosher |
| Assay Method: | HPLC |
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Product Name: Diosmin
Latin Name: Citrus aurantium L.
Specification: Diosmin 90%, 9:1
Test Method:HPLC
Part of used: Fruit
Appearance: Greyish-yellow powder
| TECHNICAL DATE SHEET | ||
| PRODUCT SPECIFICATIONS | ||
| Product Name: | Diosmin 90% granule | |
| Botanic Name: | Citrus aurantium L. | |
| Scientific name(Family/Genus/Species) | Rutaceae/Citrus/C.x aurantium | |
| Part of plant | Fruit | |
| Solvent extraction | 50% water & 50% ethanol | |
| Country of Origin: | China | |
| Excipent | None | |
| ANALYSIS ITEMS | SPECIFICATION | TEST METHOD |
| Appearance | Granule | Organoleptic |
| Color | Greyish-yellow or pale brown | Visual |
| Odour & Taste | Characteristic | Organoleptic |
| Identification A. Infrared absorption spectrophotometry(2.2.24) B.Examine the chromatorgrams obtained in the Assay |
Comparaison diosmin CRS The principal peak in the chromatorgram obtained with the test solution issimilar in retention time and size to the principal peak in the chromatogram obtained withreference solution(a) |
HPTLC |
| Solubility | Practically insoluble in water, soluble in dimethyl sulphoxide, practically insoluble in alcohol, It dissolves in dilute solutions of alkali hydroxides | |
| Diosmin | NLT 90.0% | HPLC |
| Hydrocarbons PAHs | ≤ 50 ppb -Reg.UE 1933/2015 | GC-MS |
| Benzo(a)pyren | ≤ 10 ppb -Reg.UE 1933/2015 | GC-MS |
| Iodine | ≤0.1% | |
| Impurity A: acetoisovanillone | ≤1.0% | HPLC |
| Impurity C: isorhoifin | ≤3.0% | HPLC |
| Impurity E: linarin | ≤3.0% | HPLC |
| Impurity F: diosmitin | ≤3.0% | HPLC |
| Radioactivity | ≤ 600 Bq/Kg -Reg. CE 1409/2009 | |
| Apparent density | 0.3-0.8g/ml | |
| Sieve Analysis | 80% through 24 mesh | USP39 <786> |
| Loss on drying | ≤ 6.0% | Eur.Ph.9.0 [2.5.12] |
| Total Ash | ≤ 0.2% | Eur.Ph.9.0 [2.4.16] |
| Lead (Pb) | ≤ 3.0 mg/kg | Eur.Ph.9.0<2.2.58>ICP-MS |
| Arsenic (As) | ≤ 1.0 mg/kg | Eur.Ph.9.0<2.2.58>ICP-MS |
| Cadmium(Cd) | ≤ 1.0 mg/kg | Eur.Ph.9.0<2.2.58>ICP-MS |
| Mercury(Hg) | ≤ 0.1 mg/kg -Reg.EC629/2008 | Eur.Ph.9.0<2.2.58>ICP-MS |
| Heavy metal | ≤ 10.0 mg/kg | Eur.Ph.9.0 <2.4.8> |
| Solvents Residue | Conform Eur.ph. 9.0 <5,4 > and EC European Directive 2009/32 | Eur.Ph.9.0<2.4.24> |
| Pyidine | Free | HPGC |
| Ethanol | ≤5000ppm | HPGC |
| Pesticides Residues | Conform Regulations(EC) No.396/2005 including annexes and successive updates Reg.2008/839/CE | Gas Chromatography |
| Aerobic bacteria(TAMC) | ≤1000 cfu/g | USP39 <61> |
| Yeast/Moulds(TAMC) | ≤100 cfu/g | USP39 <61> |
| Bile-tol.gram- b./Enterobact.: | ≤100 cfu/g | |
| Escherichia coli: | Absent in 1g | USP39 <62> |
| Salmonella: | Absent in 25g | USP39 <62> |
| Staphylococcus aureus: | Absent in 1g | |
| Aflatoxins B1 | ≤ 5 ppb -Reg.EC 1881/2006 | USP39 <62> |
| Aflatoxins ∑ B1, B2, G1, G2 | ≤ 10 ppb -Reg.EC 1881/2006 | USP39 <62> |
| Irradiation | No Irradiation | |
| GMO | Product No-GMO (Reg.1829/2003-1830/2003 EC) | |
| Allergens | Non allergen, in compliance with Reg.1169/2011 Annex II | |
| BSE/TSE | Free, the product doesn't contain animal materials | |
| Melamine | Free, No melamine(Reg.EU 594/2012) | |
| Ethylen-oxide | No Ethylen-oixde | |
| Vegan | Yes | |
| Packing | Pack in paper-drums and two plastic-bags inside N.W. 25 kgs I.D.35xH51cm. | |
| Storage | Store in a well-closed container away from moisture, light, oxygen. | |
| Shelf Life | 24 months under the conditions above and in its original packaging | |
1. Treatment of venous lymphatic insufficiency associated symptoms (heavy legs, pain, discomfort, soreness early morning) - the treatment of acute hemorrhoid attack on a variety of symptoms.
2. With vitamin P-like effects, can reduce vascular fragility and abnormal permeability, but also for the control of the adjuvant treatment of hypertension and arteriosclerosis, for the treatment of capillary fragility was better than rutin, hesperidin and stronger, and has low toxicity characteristics.
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