Kalmegh Extract (Andrographis paniculata)

Kalmegh Extract (Andrographis paniculata)

Andrographis paniculata (Burm.f.) Wall. ex Nees · 10-50% andrographolides by HPLC

Andrographis paniculata aerial-part extract standardised by HPLC at 10, 20, 30 or 50% andrographolides, assayed against USP reference standards. Intensely bitter.

Specifications

Botanical sourceAndrographis paniculata (Burm.f.) Wall. ex Nees (Acanthaceae). Kalmegh, Kirata or Kalpanath; English creat, green chiretta, King of Bitters.
Plant partDried aerial parts (herb), harvested at flowering. Leaf-enriched selection available where a higher native andrographolide content is wanted.
Extract type and solventEthanol or hydro-alcoholic extraction, concentrated and dried. Ratio grades 4:1 and 10:1 also offered. Residual solvents to USP <467> / Ph. Eur. 2.4.24.
StandardisationAndrographolide or total andrographolides at 10%, 20%, 30% or 50% by HPLC. Higher-purity andrographolide on enquiry. Basis is fixed in writing before order.
Total andrographolides basisSum of andrographolide, 14-deoxyandrographolide and neoandrographolide. Not interchangeable with an andrographolide-only assay at the same nominal percentage.
Marker compoundAndrographolide, CAS 5508-58-7, C20H30O5, MW 350.45, a labdane diterpene lactone. USP Andrographolide RS and Powdered Andrographis Extract RS are available.
Identity controlMacroscopy of the incoming herb plus HPTLC fingerprint against authenticated A. paniculata, run in addition to the HPLC assay to exclude related species.
Appearance and tasteLight buff to greenish-brown fine powder, characteristic odour, intensely and persistently bitter. Bitterness rises with the standardisation level.
Particle sizeNLT 95% passing 80 mesh (about 180 micron). Coarser 40 and 60 mesh cuts on request for direct-compression and granulation lines.
SolubilitySparingly soluble in water; soluble in ethanol and methanol. Water-dispersible spray-dried grade available where an aqueous system is required.
Typical purity limitsLoss on drying NMT 5.0%; total ash NMT 5.0% carrier-free basis; heavy metals to USP <2232>; pesticide residues to USP <561> or EU MRLs as specified.
MicrobiologyTPC NMT 10,000 cfu/g; yeast and mould NMT 500 cfu/g; E. coli, Salmonella and S. aureus absent. Steam-sterilised low-count grade available.
Allergen and diet statusVegan and vegetarian, plant-derived, non-GMO. Free from milk, egg, soy, fish, crustacean, peanut, tree nut and gluten-containing cereals. Not bovine or porcine.
Shelf life, storage24 months unopened, below 25 C at under 60% RH, protected from light and moisture.
HS code13021919
Kalmegh extract is made from the dried aerial parts of Andrographis paniculata (Burm.f.) Wall. ex Nees, an Acanthaceae annual native to the Indian subcontinent and known in trade as the King of Bitters. Thovek offers it standardised by HPLC at 10%, 20%, 30% and 50% andrographolides, with higher-purity andrographolide available on enquiry. One point decides the price: where a buyer specifies total andrographolides, the figure is the sum of andrographolide, 14-deoxyandrographolide and neoandrographolide, whereas a specification naming andrographolide alone counts only that peak. The two bases are not interchangeable and quotations state which one applies. Andrographolide is a labdane diterpene lactone, CAS 5508-58-7, molecular formula C20H30O5, molecular weight 350.45. USP lists both an Andrographolide Reference Standard and a Powdered Andrographis Extract Reference Standard, so the assay can be run against pharmacopoeial reference material instead of an in-house working standard - worth asking any supplier to confirm. Published survey work on commercial Andrographis products has found labelling inaccuracies and contamination, so identity here is established by macroscopy and HPTLC fingerprint alongside the assay, not by assay alone. Buyers positioning the ingredient in Europe should also note that the EMA's Committee on Herbal Medicinal Products closed its assessment of Andrographis paniculata leaf with a public statement and did not adopt an EU herbal monograph. Formulators should plan around the bitterness rather than discover it at pilot scale. Andrographolide is intensely bitter and only sparingly soluble in water, so the extract performs best in two-piece capsules, film-coated tablets and masked or encapsulated liquid systems, and poorly in open powders, chewables and unflavoured beverages. The material is vegan and vegetarian, plant-derived, non-GMO, and free from milk, egg, soy, fish, crustacean, peanut, tree nut and gluten-containing cereals. Export packing is 25 kg fibre drums with double food-grade liners, with 1 kg and 5 kg foil pouches for trials. Permitted use of Andrographis in food supplements varies between markets, and confirming status for the destination country remains the importer's responsibility.

Applications

Two-piece capsule blendsFilm-coated tablet granulationAyurvedic proprietary medicinesHerbal bitters and tonicsMasked liquid shotsMulti-herb botanical stacksSeasonal wellness formulasAnimal nutrition premixes

Available grades

Standardised on andrographolide or on total andrographolides by HPLC at 10%, 20%, 30% and 50%; higher-purity andrographolide on enquiry. Native ratio grades 4:1 and 10:1. Leaf-enriched selection for higher native andrographolide. Water-dispersible spray-dried grade, steam-sterilised low-microbial grade, granulation mesh cuts, and certified organic (NOP/EU) on contract.

Packaging: 25 kg fibre drums with double food-grade LDPE liners, palletised and shrink-wrapped. 1 kg and 5 kg aluminium-foil laminate pouches for samples and pilot lots; nitrogen flushing on request. The powder is very bitter and airborne dust carries the taste through a plant, so decant under local exhaust and keep liners resealed. Store below 25 C at under 60% RH, away from direct light.

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