Hard capsules of Crataegus monogyna and C. laevigata leaf-and-flower dry extract, standardised to Ph. Eur. flavonoid levels. Vegan HPMC or bovine gelatin shell, bulk drums or private-label jars.
| Botanical source | Crataegus monogyna Jacq. and Crataegus laevigata (Poir.) DC. (syn. C. oxyacantha), leaf with flower — Crataegi folium cum flore, family Rosaceae |
| Herbal substance quality | Ph. Eur. hawthorn leaf and flower: minimum 1.5% total flavonoids expressed as hyperoside, calculated on the dried drug |
| Extract type and DER | Hydroalcoholic dry extract, drug-to-extract ratio 4-7:1, ethanol 45-70% V/V; aqueous dry extract also produced |
| Standardisation | Minimum 6.0% total flavonoids as hyperoside (hydroalcoholic) or minimum 2.5% (aqueous), per the Ph. Eur. hawthorn leaf and flower dry extract monograph |
| Alternative declaration | Oligomeric procyanidin (OPC) standardised grades quoted separately; flavonoid and OPC figures are distinct assays and are not interchangeable |
| Characterised constituents | Vitexin, vitexin-2''-O-rhamnoside, isovitexin, hyperoside, quercetin; (+)-catechin, (-)-epicatechin and oligomeric procyanidins; triterpene acids |
| Capsule fill and size | 250 mg, 300 mg or 500 mg extract per capsule, size 0 or size 1; excipients limited to microcrystalline cellulose and magnesium stearate or silica |
| Capsule shell | HPMC (hypromellose) vegan shell as standard; bovine gelatin shell on request, which changes the dietary declaration on the finished pack |
| Appearance | Light brown to reddish-brown fine powder in a clear or opaque shell; characteristic faint odour, astringent taste |
| Loss on drying / solvent | Extract loss on drying not more than 5.0%; residual ethanol within ICH Q3C Class 3 limits, not more than 5000 ppm |
| Microbiology | Total plate count max 10,000 cfu/g; yeast and mould max 1,000 cfu/g; E. coli absent in 10 g; Salmonella absent in 25 g |
| Allergen and dietary status | No milk, egg, soy, fish, crustacean, gluten, peanut or tree nut input. Vegan and vegetarian with HPMC shell; bovine if gelatin shell is specified |
| Shelf life and storage | 24 months from manufacture in unopened original packaging, below 25 C and under 60% RH, protected from light and moisture |
| HS code | India ITC-HS 2106 90 99 as a finished supplement in dosage form; unencapsulated bulk extract falls to 1302 19 19 |
Hydroalcoholic dry extract capsules at minimum 6% total flavonoids as hyperoside (standard); aqueous dry extract capsules at minimum 2.5%; OPC-standardised grades quoted to specification; hawthorn berry (Crataegi fructus) extract capsules; HPMC vegan or bovine gelatin shell; organic-certified extract (NPOP/NOP/EU) on request.
Capsules of Monascus purpureus fermented rice extract with monacolin K declared by HPLC and citrinin controlled to the EU limit per lot. Vegan, gluten-free, made in India with full export documentation.
Free plant sterol powder from vegetable oil deodoriser distillate or tall oil, with β-sitosterol, campesterol and stigmasterol profiled by GC-FID. Bulk powder, dispersible grades and capsules from India.
Tablets of sugar cane wax policosanol, a C24-C34 primary aliphatic alcohol mixture led by 1-octacosanol and profiled by GC. Bulk powder also supplied. Vegan, gluten-free, made in India.