Tribulus Terrestris Extract Usp Monograph Upd | 1080p |
A monograph is a written document that establishes public specifications for an article's quality. For a botanical extract, it typically includes: Definition:
To meet USP standards, the extract must pass several analytical tests: Test Category Standard Requirement Common Methodology
If the extraction process used organic solvents (e.g., ethanol, methanol, ethyl acetate), the monograph mandates compliance with USP <467>. For example: tribulus terrestris extract usp monograph
The solves this by standardizing the extract to specific marker compounds, ensuring batch-to-batch consistency.
| Parameter | USP Limit | | :--- | :--- | | | Not more than (NMT) 2.0% | | Total ash | NMT 15.0% | | Acid-insoluble ash | NMT 5.0% | | Loss on drying | NMT 8.0% (for extract powder) | | Heavy metals | NMT 10 ppm for lead; NMT 1 ppm for mercury; NMT 3 ppm for cadmium | | Arsenic | NMT 2.5 ppm | | Pesticide residues | Complies with USP <561> (e.g., DDT, aldrin, endrin) | | Microbial enumeration | Total aerobic count NMT 10^4 cfu/g; absence of Salmonella and E. coli | | Aflatoxins | B1 NMT 2 ppb; total B1+B2+G1+G2 NMT 4 ppb | A monograph is a written document that establishes
To ensure safety and quality, the monograph sets strict limits on several parameters:
In the rapidly growing global market for botanical dietary supplements, Tribulus terrestris has emerged as a dominant ingredient, widely recognized for its traditional use in vitality and modern application in sports nutrition. However, with great demand comes great risk: adulteration, misidentification, and inconsistent active compound levels plague the supply chain. | Parameter | USP Limit | | :---
Verification of diagnostic features such as sharp spines on the fruit, bright yellow flowers, and specific trichomes or calcium oxalate crystals in powder form.
While USP is U.S.-centric, many pharmacopeias (e.g., Indian Pharmacopoeia, European Pharmacopoeia) are converging. A USP-compliant extract meets or exceeds many international standards, easing exports to the EU, Japan, and Australia.
While the USP monograph focuses on quality control, the European Medicines Agency (EMA) and other bodies evaluate its traditional uses. The standardized extract is primarily researched for: Public statement on Tribulus terrestris L., herba - EMA
A USP monograph is a set of standards and specifications established by the United States Pharmacopeia (USP) for a particular dietary supplement or herbal remedy. The monograph provides a detailed description of the supplement, including its identity, purity, and potency. The USP monograph for Tribulus terrestris extract sets forth specific requirements for the extract's: