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Food and Nutrition Ingredients

Food and Nutrition Ingredients

Pregnenolone


Pregnenolone (CAS:145-13-1) is a natural steroidal compound known as the master precursor of all human steroid hormones. White crystalline powder, fat-soluble, absorbed well via oral delivery. Inside the human body, it converts into progesterone, estrogen, testosterone, DHEA and cortisol to balance overall hormone levels. Widely applied in sleep support, stress relief, cognitive health and comprehensive anti-aging dietary supplements.

We supply two mainstream grades: 99% food grade pure pregnenolone powder and slow-release microcapsule pregnenolone for mild absorption. All batches pass strict impurity & heavy metal control, fully compliant with FDA GRAS, ISO22716, GMP, HALAL & KOSHER standards. Free formulation samples and complete COA & SDS documents are available for brand testing.

Pregnenolone
Master Hormone Precursor
99% Food Grade
Oral Supplement Raw Material
HALAL & KOSHER Certified

PRODUCT INTRODUCTION

Complete Technical Specification (Pregnenolone Food Grade)


Product Name Pregnenolone, Food Grade Steroid Precursor
CAS No. 145-13-1
Molecular Formula C₂₁H₃₂O₂
Molecular Weight 316.48 g/mol
Appearance (Pure Powder) White fine crystalline powder, odorless
Appearance (Microcapsule) Off-white uniform free-flowing microcapsule powder
Pregnenolone Assay (HPLC) ≥99.0% (pure powder); 10%/20% core content for microcapsule
Related Steroid Impurities Single unknown impurity ≤0.1%, total impurities ≤0.5%
Solubility Insoluble in water; soluble in ethanol, vegetable oil, organic ester solvents
Melting Point 187 ~ 193℃
Loss on Drying ≤0.3%
Residue on Ignition ≤0.1%
Heavy Metals Pb ≤0.1ppm, As ≤0.1ppm, Cd ≤0.05ppm, Hg ≤0.01ppm, food grade compliant
Microbiology TPC ≤100cfu/g, Yeast & Mold ≤10cfu/g, Pathogens Negative
Allergen Status Non-GMO, Vegan, No dairy, gluten or animal allergens
Storage Condition Sealed light-proof vacuum packaging, cool dry warehouse below 25℃, avoid high humidity & direct sunlight
Unopened Shelf Life 24 months under recommended storage environment
MOQ 10g sample order, 100g / 1kg / 5kg / 25kg bulk vacuum packaging

Core Benefits & Functional Mechanism of Pregnenolone


Pregnenolone is the foundational steroidal precursor upstream of all endogenous human hormones. After oral absorption, it enters adrenal and gonadal tissue to synthesize DHEA, progesterone, testosterone and estrogen, balancing declining hormone levels caused by aging. It also modulates GABA and cortisol pathways in the brain to calm nervous tension, extend deep sleep duration and support long-term cognitive function.

Pure pregnenolone powder suits high-concentration capsule formulas; microcapsule version slows gastrointestinal release to avoid mild stomach discomfort. It forms synergistic anti-aging compound formulas with DHEA, NAD+, resveratrol, magnesium and melatonin, widely adopted by cross-border aging-support supplement brands.

  • Master hormone precursor: upstream raw material for all steroid hormones, balance multi-hormone levels naturally
  • Improve sleep quality: prolong deep sleep phase, reduce frequent midnight waking & insomnia trouble
  • Relieve chronic stress: regulate cortisol secretion, ease anxiety, mental fatigue and mood swings
  • Support cognitive anti-aging: maintain memory, mental clarity and brain vitality for middle-aged & elderly
  • Full-body anti-aging support: relieve aging fatigue, improve dull skin and low physical stamina
  • Dual optional forms: pure high-purity powder & mild slow-release microcapsule for diverse product lines

Formulation & Usage Tip: Daily oral finished dosage 10–50mg per serving; microcapsule recommended for sensitive stomach customers; store finished capsules in amber light-proof bottles; pregnant, lactating and hormone disorder populations require professional medical advice before consumption.

Pregnenolone hormone conversion pathway mechanism diagram

Pregnenolone Biochemical Synthesis & Low-Temp Purification Process


Full Manufacturing Steps

  1. Plant sterol precursor raw material screening, heavy metal & residual solvent pre-inspection
  2. Biocatalytic directional conversion under closed low-temperature nitrogen protection
  3. Multi-stage recrystallization purification to separate related steroid impurities
  4. Membrane filtration & decolorization to remove pigment and macromolecular byproducts
  5. Vacuum low-temperature drying to obtain 99% pure pregnenolone crystal powder
  6. Optional microcapsule embedding: wrap with food-grade biodegradable shell for slow release
  7. HPLC full purity & impurity testing, light-proof vacuum nitrogen-filled sealed packaging

GMP steroidal active ingredient closed production workshop, full low-temperature anti-oxidation process, strict control of single unknown impurities, stable batch purity and safety indicators, fully meet global food supplement raw material export standards.

Pregnenolone closed GMP synthesis purification production line

Factory Supply Capacity & Global Export Certifications


Specialized GMP steroidal supplement raw material production base, annual pregnenolone total output reaches 9 tons, 800kg regular spot inventory, independent constant temperature dark warehouse to avoid light-induced degradation, stable bulk supply for cross-border hormone balance anti-aging supplement OEM factories.

Stable Bulk Supply Advantages

  • Annual production capacity: 9 tons of 99% pregnenolone powder & microcapsule series
  • Ready spot stock: 800kg standard two grades for fast delivery
  • Custom microcapsule core content, multi-ingredient hormone balance premix powder
  • 5~7 working days fast delivery for standard bulk orders, long-term framework preferential pricing
halal

Batch COA & SDS Full Official Documents

  • ISO22716 / GMP Food Supplement Raw Material Production Specification
  • US FDA GRAS qualified, EU food safety filing compliant
  • HALAL & KOSHER dual global religious export certification
  • Third-party full impurity & heavy metal safety testing, full batch traceability system
  • REACH, overseas health food registration supporting documents

6 Core Competitive Advantages of Our Pregnenolone


99% Ultra-High Purity Low Impurity

Multi-stage recrystallization purification, total related impurities strictly controlled ≤0.5%, meet high-end supplement standards.

Master Hormone Precursor Synergy

Upstream of all steroid hormones, perfect compound match with DHEA, NAD+ for full anti-aging formulas.

Two Forms For All Product Lines

99% pure crystal powder for high-dose capsules & slow-release microcapsule for sensitive stomach customers.

Excellent Oral Absorption

Good lipophilicity, high bioavailability in capsule, tablet and oil suspension oral systems.

Global Food Safety Compliant

FDA GRAS & EU food certified, HALAL/KOSHER dual certification, full filing docs for cross-border brands.

Custom Compound Premix Service

Custom microcapsule concentration, hormone balance blended powder, packaging & oral formulation technical guidance.

Request Free Sample & Bulk Quotation

Looking for a reliable supplier of high purity Pregnenolone raw material for hormone balance supplements, anti-aging capsules and wellness nutritional formulations?

Contact our team today to receive free samples, full COA specifications, global export certification documents and customized bulk pricing for your hormone support health raw material project.

Get Free Sample & Quote

Main Industrial Application Fields for Pregnenolone


Sleep Support Capsules

Improve insomnia, extend deep sleep, reduce midnight wake-up frequency

Hormone Balance Supplements

Middle-aged hormone regulation, relieve menopause & andropause discomfort

Cognitive & Memory Support Tablets

Maintain mental clarity, anti-brain aging for elderly groups

Stress Relief Anti-Fatigue Powder

Relieve chronic mental stress, improve long-term physical exhaustion

Sports Recovery Nutrition

Balance exercise-induced hormone fluctuation, accelerate physical recovery

Compound Full-Body Anti-Aging Complex

Match DHEA/NAD+/Resveratrol for multi-dimensional aging care series

Strict QC Testing & Official Batch Compliance Documents


Each pregnenolone batch undergoes full HPLC testing for main content, single & total steroid impurities, loss on drying, ignition residue, heavy metals, residual solvents and complete microbial inspection, fully compliant with ISO22716, FDA GRAS and EU food supplement raw material standards.

We provide exclusive batch COA, HPLC spectrum test report, SDS safety data sheet, HALAL/KOSHER/ISO/GMP certification copies, third-party food safety evaluation reports and full batch traceability records, supporting supplement factory audits, global health food registration and customs clearance.

Full Batch Traceability System

Unique batch number, complete synthesis, purification and testing records, permanent traceability for food supplement compliance audits

OEM & Custom Formulation Service for Pregnenolone


Customizable Service Range

  • 99% pure pregnenolone crystal powder particle fineness customization
  • Custom core content microcapsule pregnenolone (10% / 20% core load)
  • Multi-ingredient hormone balance premix: Pregnenolone + DHEA + NAD+ + Magnesium
  • Bulk light-proof vacuum packaging: 100g /1kg /5kg /25kg, customizable outer private label packaging
  • Oral capsule, tablet, powder drink formulation technical guidance, stability & absorption testing support

Support long-term framework bulk orders with stable purity and low impurity indicators, supply complete regulatory documents including batch COA, SDS, test reports and certification copies to help cross-border health food brands complete regional filing and customs clearance.

Light-proof vacuum customized bulk pregnenolone raw material packaging

How to buy Pregnenolone ?

Please feel free to contact us for any of your needs. You can send an email to admin@focusherb.com or submit your request at the bottom of the page. We will be happy to assist you!

Top Frequently Asked Questions about Pregnenolone Powder


1. What is the CAS number, molecular formula and purity specification of your Pregnenolone Powder?

Our pregnenolone raw material is pharmaceutical & cosmetic grade with CAS: 145-13-1, molecular formula C₂₁H₃₂O₂.

Standard purity ≥99% tested by HPLC, white crystalline powder.

We provide complete batch COA, HPLC chromatogram, melting point test and impurity analysis reports. Strictly separated from related steroid intermediates to avoid cross-contamination.

2. What safety and impurity tests are carried out for each batch?

Every batch undergoes full inspection: heavy metals (Pb, As, Cd, Hg), residual organic solvents, unknown single/total impurities, microbial limits (TPC, yeast & mold, pathogenic bacteria), moisture and loss on drying.

Comply with USP, EP, ISO22716, GMP standards. Full test documents support dietary supplement registration, cosmetic filing, factory audits and customs clearance worldwide.

3. What are core applications and recommended dosage range?

Main applications: oral dietary supplement capsules, softgels, hormone balancing skincare, anti-aging topical formulations, nutraceutical raw materials.

Dosage varies by finished product category; follow local regulatory maximum limits for oral and cosmetic use.

It is stable under neutral pH; avoid strong acid, strong alkali and long-term high-temperature heating to prevent structural degradation. Pre-formulation compatibility test is required before mass production.

4. What is shelf life and proper storage condition?

Unopened sealed powder: 24 months under cool, dry, dark storage (2–8°C recommended), away from direct sunlight, heat and humidity.

Once opened, seal tightly and finish usage as soon as possible to prevent moisture absorption and purity decline.

Liquid formulations based on pregnenolone have a shorter shelf life subject to preservative systems.

5. What is the difference between pregnenolone and other steroid raw materials like DHEA?

Pregnenolone is the foundational precursor steroid in the human body, used as the starting material to synthesize DHEA, progesterone, cortisol and sex hormones, with unique regulating effects on adrenal and nervous comfort.

DHEA is a downstream derivative with different metabolic pathways, applicable dosage and regulatory classification. They cannot be substituted directly in formulas.

6. Is Pregnenolone Powder vegan, non-GMO and HALAL/KOSHER available?

Our synthetic pregnenolone powder is vegan, cruelty-free, gluten-free, non-GMO, without parabens, artificial flavors or animal-derived additives.

HALAL and KOSHER certification documents can be supplied for global export orders upon request. It has low irritation risk for topical use, but oral finished goods need strict compliance with local health authority regulations.

7. What is MOQ, packaging and delivery time?

Sample MOQ: 10g for formulation testing & lab trials

Bulk MOQ: 1kg / 5kg / 25kg export packaging (light-proof aluminum foil bags, sealed drums)

In-stock standard orders: 3–7 working days delivery

Custom micronized powder or liquid premix formulations: 7–14 working days

Long-term framework bulk orders are supported for stable batch purity and consistent supply.

8. Can I get free test samples and full compliance documents?

Qualified bulk buyers can apply for 10g free samples for lab testing and formulation compatibility verification.

We offer batch COA, SDS (MSDS), HPLC reports, GMP & ISO certificates, full batch traceability records, which support supplement/cosmetic registration and cross-border import clearance.

9. Will pregnenolone cause discoloration or degradation in finished formulas?

High-purity pregnenolone powder has stable color under proper pH and storage environment. Discoloration and degradation only occur under high temperature, strong acid/alkali or prolonged light exposure.

We suggest controlling production temperature below 40°C and adopting opaque packaging for finished products to extend shelf stability.

10. Do you support third-party testing and factory on-site audits?

Our production base follows GMP and ISO22716 standardized production management. We accept independent third-party lab testing, customer factory audits and provide complete quality control records and full batch traceability data.

Have any questions?
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