ALA
5-Aminolevulinic Acid
Key Specifications
| CAS Number | 106-60-5 |
| Purity | ≥98.0% |
| Molecular Formula | C₅H₉NO₃ |
| Molecular Weight | 131.13 g/mol |
| Appearance | White crystalline powder |
| Solubility | Freely soluble in water |
| Storage | 2–8°C, protect from light |
| Shelf Life | 24 months |
CAS 106-60-5
What Is ALA?
5-Aminolevulinic acid (5-ALA, CAS 106-60-5) is a naturally occurring non-protein amino acid with the molecular formula C5H9NO3 and a molecular weight of 131.13 g/mol. It is the first committed intermediate in the tetrapyrrole (porphyrin/heme and chlorophyll) biosynthetic pathway found in nearly all living cells, from bacteria to plants and humans. While trace amounts occur naturally in the body, commercial bulk 5-ALA is produced industrially through microbial fermentation: engineered production strains (commonly E. coli or yeast) overexpressing 5-aminolevulinic acid synthase are cultivated under controlled fed-batch conditions, after which the target molecule is recovered and purified from the fermentation broth using chromatographic separation and crystallization.
Other Names
Key Features
High-Purity ≥98.0%
Each batch is manufactured and tested to a guaranteed minimum assay of 98.0%, verified by HPLC against a certified reference standard prior to release.
Controlled Biosynthetic Production
Produced via a synthetic biology fermentation platform using engineered microbial strains and enzymatic (ALA synthase-driven) conversion, giving consistent batch-to-batch quality without reliance on plant extraction.
Consistent White Crystalline Form
Supplied as a uniform white crystalline powder that is freely soluble in water, simplifying handling, weighing, and downstream formulation.
Verified Contaminant Testing
Every lot is screened for heavy metals (Pb, Hg, Cd, As) and microbial limits (total plate count, yeast/mold, E. coli, Salmonella) to support finished-product safety compliance.
Flexible Bulk & OEM Supply
Available in flexible bulk quantities with custom packaging, labeling, and OEM/private-label documentation to fit supplement, cosmetic, and agricultural customer requirements.
| Molecular Formula | C₅H₉NO₃ |
| Molecular Weight | 131.13 g/mol |
| Appearance | White crystalline powder |
| Solubility | Freely soluble in water |
| Storage Condition | 2–8°C, protect from light |
| Shelf Life | 24 months |
| Grade 1 | Phosphate Salt · ≥98.0% · COA |
| Grade 2 | Hydrochloride Salt · ≥98.0% · COA |
End-Product Applications
Mechanism & Benefits
Promotes hemoglobin synthesis, improves hypoxic conditions, supports sleep regulation and immune enhancement.
Packaging Options
1 kg 5 kg 25 kg
Lead Time
5–7 business days
Minimum Order
1 kg
Custom Packaging
Custom packaging (foil bags, HDPE drums), GMP labeling, and export documentation are available. Contact us for specifics.Certifications
ISO
ISO
ISO9001
ISO 9001
Manufacturing Process
Strain Engineering & Seed Culture
A production microorganism (typically E. coli or yeast) engineered to overexpress 5-aminolevulinic acid synthase and related pathway enzymes is revived and expanded through seed culture stages to build sufficient healthy biomass.
Fed-Batch Fermentation
Seed culture is transferred into production bioreactors where temperature, pH, dissolved oxygen, and feeding of carbon source and precursors (e.g., glycine) are tightly controlled to drive enzymatic conversion into 5-ALA via the biosynthetic pathway.
Broth Clarification
Fermentation broth is harvested and cell biomass is removed by centrifugation and/or microfiltration, yielding a clarified liquid containing dissolved 5-ALA.
Chromatographic Capture & Decolorization
The clarified broth is passed through ion-exchange resin to selectively capture 5-ALA, followed by decolorization steps to remove pigments and fermentation by-products.
Concentration & Crystallization
The purified 5-ALA solution is concentrated under controlled conditions and induced to crystallize, producing a defined crystal form suited for stable bulk handling.
Drying & Milling
Crystals are separated, dried under low-temperature and light-protected conditions to minimize degradation, and milled/sieved to achieve the target particle size and uniform white powder form.
Quality Testing
Each batch undergoes HPLC assay, appearance, moisture, heavy metals, and microbial testing against internal and pharmacopoeia-referenced specifications before release.
Packaging & Storage
Finished 5-ALA is packed in moisture-proof, light-protective containers under inert or desiccant-controlled conditions and stored/shipped cold or ambient with recommended cool, dry, dark storage to preserve stability.
Quality Specifications
| Test Item | Specification | Result |
|---|---|---|
| Appearance | White to off-white crystalline powder | White crystalline powder, conforms |
| Odor | Odorless or nearly odorless | Conforms |
| Assay (HPLC) | ≥98.0% | 98.6% |
| Particle Size | 100% through 80 mesh | Conforms |
| Loss on Drying | ≤1.0% | 0.4% |
| Residue on Ignition (Sulfated Ash) | ≤0.5% | 0.2% |
| pH (1% aqueous solution) | 3.0–5.0 | 3.9 |
| Lead (Pb) | ≤2 ppm | <1 ppm |
| Mercury (Hg) | ≤1 ppm | <0.1 ppm |
| Cadmium (Cd) | ≤1 ppm | <0.5 ppm |
| Arsenic (As) | ≤2 ppm | <1 ppm |
| Total Plate Count | ≤1000 CFU/g | <100 CFU/g |
| Yeast & Mold | ≤100 CFU/g | <10 CFU/g |
| E. coli / Salmonella | Negative/25g | Negative |
Purity & Assay Method
Purity is determined by high-performance liquid chromatography (HPLC) against a certified 5-ALA reference standard, typically after suitable derivatization or at a low-UV wavelength given the molecule's weak native chromophore. Because 5-ALA can exist as the free acid (as here, MW 131.13) or as more stable salt forms (e.g., hydrochloride, MW ~167.6), buyers should always confirm the exact salt form, assay basis, and certificate of analysis for each batch before calculating dosage or label claims.
Solubility & Formulation
5-ALA is freely soluble in water, allowing straightforward incorporation into aqueous solutions, drops, and beverage-type formats. Because the compound is sensitive to heat, light, and elevated pH — conditions that can promote self-condensation into pyrazine-type degradation products — formulators are advised to work in mildly acidic aqueous systems, minimize prolonged heat exposure during processing, and protect finished formulations from light. For solid dosage forms (capsules, tablets) and agricultural foliar sprays, compatibility testing with excipients or tank-mix partners is recommended to confirm stability under intended storage and use conditions.
Available Product Forms
Bulk ALA Powder
High-purity raw powder for supplement factories, research organizations, ingredient distributors, and contract manufacturers.
ALA Capsules
Custom capsule strength, shell material, bottle count, excipients, and label design for private-label brands.
ALA Tablets
Tablet formulation, granulation, compression, coating, bottle packaging, and custom labeling support.
ALA Powder Blends
ALA can be blended with complementary actives (antioxidants, other longevity ingredients, vitamins, minerals) per customer formula.
How is the ≥98.0% purity specification verified?+
Each production batch is tested by HPLC against a certified reference standard, and a certificate of analysis (COA) covering assay, appearance, and impurity limits is issued with every shipment. Third-party retesting is welcomed and pre-shipment samples can be arranged.
How is this 5-ALA produced — is it fermentation-derived or chemically synthesized?+
Our 5-ALA is produced via a controlled microbial fermentation and enzymatic conversion platform using engineered production strains, rather than plant extraction or purely chemical synthesis. This biosynthetic route supports consistent quality and scalable, traceable production.
What is the solubility of this material and how should it be handled?+
5-ALA is freely soluble in water. It is moisture- and light-sensitive, so we recommend storing it in a cool, dry, dark place in its original sealed packaging and minimizing exposure once opened.
Can we request a sample before placing a bulk order?+
Yes, small samples are available for evaluation purposes, typically accompanied by the current COA and safety data sheet. Please contact our sales team with your intended application to arrange a sample.
Can we arrange independent third-party testing?+
Yes, we support third-party laboratory verification of purity, heavy metals, and microbial limits, and can facilitate sample submission to a testing lab of your choice.
Do you offer OEM or private-label services?+
Yes, we offer OEM/private-label support including custom packaging, labeling, and documentation to meet regulatory requirements in your target markets, for dietary supplement, cosmetic, and agricultural applications.
What packaging options are available?+
Standard packaging includes moisture-proof, light-protective aluminum foil bags or drums in various bulk sizes, with desiccant included where appropriate. Custom packaging sizes and materials can be discussed based on order volume.
What is the minimum order quantity (MOQ) and how do we request a quotation?+
MOQ varies by intended use and packaging format; please contact our sales team with your target volume, application, and destination market for a tailored quotation and lead time estimate.
Why Choose PathGene
- Direct China manufacturer supply — factory pricing, no middleman
- Batch-specific COA & full traceability on every shipment
- In-house R&D + synthetic biology / enzymatic production platform
- Free sample for qualified B2B buyers before commercial order
- Flexible MOQ — from lab-scale trial to ton-scale commercial supply
- One-stop OEM/private-label support for finished dosage forms
- Worldwide shipping by courier, air freight, and sea freight
OEM & Private-Label Services
- ·Custom capsule manufacturing
- ·Custom tablet manufacturing
- ·Powder blending & custom formulation
- ·Private-label bottles, pouches & labels
- ·Small trial orders
- ·Bulk commercial production
- ·Export documentation
- ·Third-party laboratory testing
Documents Available
- ·Certificate of Analysis (COA)
- ·Product specification sheet
- ·Material Safety Data Sheet (MSDS)
- ·Manufacturing flow chart
- ·HPLC test report
- ·Heavy-metal test report
- ·Microbiological test report
- ·Non-GMO / allergen statement
- ·Country-of-origin documentation
- ·Packing list & commercial invoice
Certificate availability should be confirmed with our sales team before ordering.
Sample Certificate of Analysis
PathGene Biotech Co., Ltd.
南京派琪生物科技有限公司
CERTIFICATE OF ANALYSIS
Layout example — not an issued batch record
Product Name
ALA
CAS No.
106-60-5
Batch No.
PG-SAMPLE-000000
Packaging
Issued upon order confirmation
| Test Item | Specification | Result |
|---|---|---|
| Appearance | White to off-white crystalline powder | White crystalline powder, conforms |
| Odor | Odorless or nearly odorless | Conforms |
| Assay (HPLC) | ≥98.0% | 98.6% |
| Particle Size | 100% through 80 mesh | Conforms |
| Loss on Drying | ≤1.0% | 0.4% |
| Residue on Ignition (Sulfated Ash) | ≤0.5% | 0.2% |
| pH (1% aqueous solution) | 3.0–5.0 | 3.9 |
| Lead (Pb) | ≤2 ppm | <1 ppm |
| Mercury (Hg) | ≤1 ppm | <0.1 ppm |
| Cadmium (Cd) | ≤1 ppm | <0.5 ppm |
| Arsenic (As) | ≤2 ppm | <1 ppm |
| Total Plate Count | ≤1000 CFU/g | <100 CFU/g |
| Yeast & Mold | ≤100 CFU/g | <10 CFU/g |
| E. coli / Salmonella | Negative/25g | Negative |
Conclusion: Conforms to internal quality specifications
The COA issued with your order will carry the actual batch number, manufacture/test dates, and QC signature.
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Interested in ALA?
Our R&D team will respond to your inquiry or sample request within 24 hours.
