Cerebrolysin

Name: Cerebrolysin
Brand: Homopeptide
Price: 50 USD
Availability: InStock

60mg*6vials

Peptides Nootropics & Cognitive

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Product Details

Catalog Number CBL60

Category Peptides

Subcategory Nootropics & Cognitive

Specification 60mg*6vials

Purity (HPLC) 99.5%+ — PeptideMeter Verified

QC Reports & Certificates of Analysis

About This Product

Cerebrolysin is a neuropeptide preparation researched for neuroprotective and cognitive enhancement effects. Studies suggest it may promote neuroplasticity, support neuronal health, and enhance cognitive function. This peptide is investigated for its potential applications in age-related cognitive decline research.

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Cerebrolysin

$50.00

Certificate of Analysis

Purity Analysis — Reversed-Phase HPLC

Report No.: COA-CBL60-2315

Page: 1/1

Classification: Internal / Confidential

Sample Information

Product Name:Cerebrolysin

Catalog No.:CBL60

Batch No.:COA-CBL60-2315

Specification:60mg*6vials

Mfg. Date:2026-03-15

Test Date:2026-03-17

Sample Weight:56.7 mg

Appearance:White to off-white lyophilized powder

Storage:-20°C, desiccated, protect from light

Quality Standard:In-house specification HP-QS-CBL60-2026

1. Analytical Method & Instrumentation

Method:Reversed-Phase HPLC per USP <621>

Instrument:Agilent 1260 Infinity II HPLC System (SN: DE37650)

Column:Agilent ZORBAX Eclipse Plus C18, 250 x 4.6 mm, 5 μm (Lot: B42442)

Mobile Phase A:0.1% Trifluoroacetic acid (TFA) in Milli-Q Water (18.2 MΩ·cm)

Mobile Phase B:0.1% TFA in Acetonitrile (HPLC Grade, Fisher Scientific)

Gradient Program:0 min → 5%B, 5 min → 20%B, 20 min → 60%B, 28 min → 95%B, 30 min → 95%B

Flow Rate / Temp:1.0 mL/min / 30.0 ± 0.5°C (thermostatted column compartment)

Detection:UV-DAD at 220 nm (bandwidth 4 nm, ref. 360 nm)

Injection:20 μL, sample conc. 0.5 mg/mL in 0.1% TFA/H₂O

Data Processing:Agilent OpenLAB CDS ChemStation Rev. C.01.10

2. System Suitability Test (SST)

Parameter	Acceptance Criteria	Result	Status
Theoretical Plates (N)	≥ 2000	15844	PASS
Tailing Factor (T)	0.8 – 1.5	1.03	PASS
Repeatability RSD (n=6)	≤ 1.0%	0.26%	PASS
Resolution (Rs)	≥ 1.5	3.8	PASS

3. Purity & Assay Results

Test Item	Specification	Result	Status
Appearance	White to off-white lyophilized powder	Conforms	PASS
Identification (FTIR)	Consistent with reference spectrum	Consistent	PASS
Purity (RP-HPLC, area%)	≥98%	99.1%	PASS
Assay (Potentiometric Titration)	98.0% – 102.0%	99.0%	PASS
Moisture (Karl Fischer, V-30S)	≤ 1.0%	0.27%	PASS
Largest Single Impurity	≤ 0.50%	0.09%	PASS
Total Impurities	≤ 2.0%	0.90%	PASS
Specific Rotation [α]²⁰_D	Literature value ± 2.0°	−28.7° (c=1, DMF)	PASS
Residual Solvents (GC-FID/HS, per ICH Q3C R8)
DMF (Class 2)	≤ 880 ppm	156 ppm	PASS
DCM (Class 2)	≤ 600 ppm	69 ppm	PASS
Methanol (Class 2)	≤ 3000 ppm	75 ppm	PASS
Acetonitrile (Class 2)	≤ 410 ppm	57 ppm	PASS
Ethyl Acetate (Class 3)	≤ 5000 ppm	206 ppm	PASS

4. HPLC Chromatogram

Fig. 1: RP-HPLC chromatogram of Cerebrolysin (Batch: COA-CBL60-2315). Main peak RT = — min, Area% = 99.1%. UV detection at 220 nm.

1. Analytical Method & Instrumentation

Standard:ICP-MS per ICH Q3D(R2) / USP <232> <233>

Instrument:Agilent 7900 ICP-MS (SN: JP67725) with He collision mode

Sample Preparation:Closed-vessel microwave digestion (CEM MARS 6): 56.7 mg + 5 mL HNO₃ (suprapure) + 1 mL H₂O₂ (30%)

Digestion Program:Ramp 20 min → 200°C, hold 15 min, cool to RT, dilute to 50.0 mL (Milli-Q)

Calibration:Multi-element std (NIST SRM 3100 series), 5-point external cal. (r² ≥ 0.999)

Internal Standards:⁴⁵Sc, ⁷²Ge, ¹⁰³Rh, ¹⁸⁵Re, ²⁰⁹Bi — 10 ppb each, online addition

Quality Control:Method blank, CRM (NIST 1577c), spike recovery (90–110%), duplicate analysis

2. Elemental Impurity Results

Element	ICH Class	PDE Oral (μg/day)	Limit (ppm)	Result (ppm)	Status
Class 1 — High Toxicity (Mandatory for human use)
Lead (Pb) — m/z 208	1	5	≤ 0.5	0.044	PASS
Cadmium (Cd) — m/z 111	1	5	≤ 0.5	0.027	PASS
Arsenic (As) — m/z 75	1	15	≤ 1.5	0.192	PASS
Mercury (Hg) — m/z 202	1	30	≤ 3.0	0.015	PASS
Class 2A — High Probability (Oral route)
Cobalt (Co) — m/z 59	2A	50	≤ 5.0	0.169	PASS
Vanadium (V) — m/z 51	2A	100	≤ 10	0.009	PASS
Nickel (Ni) — m/z 60	2A	200	≤ 20	0.597	PASS
Class 2B — Risk Assessment-Based
Palladium (Pd) — m/z 105	2B	100	≤ 10	0.280	PASS
Platinum (Pt) — m/z 195	2B	100	≤ 10	< LOD	PASS
Silver (Ag) — m/z 107	2B	150	≤ 15	0.085	PASS
Class 3 — Minimal Toxicity Concern (Oral)
Copper (Cu) — m/z 63	3	3000	≤ 300	0.13	PASS
Iron (Fe) — m/z 56	3	—	≤ 100	0.64	PASS
Nickel (Ni) — m/z 60 (low-tox)	3	—	≤ 200	0.64	PASS
Zinc (Zn) — m/z 66	3	13000	≤ 1300	2.80	PASS
Chromium (Cr) — m/z 52	3	11000	≤ 1100	0.044	PASS
Manganese (Mn) — m/z 55	3	2500	≤ 250	1.37	PASS

3. Method Validation Parameters

Parameter	Criteria	Result	Status
LOD (Class 1 Elements)	≤ J/10 of limit	As: 0.001, Cd: 0.0005, Hg: 0.0003, Pb: 0.001 ppm	PASS
LOQ (Class 1 Elements)	≤ J/2 of limit	As: 0.005, Cd: 0.002, Hg: 0.001, Pb: 0.005 ppm	PASS
Spike Recovery	70–150% (per USP <233>)	96.0% – 102.0%	PASS
Repeatability (n=3)	RSD ≤ 20%	3.7%	PASS
Method Blank	< LOQ for all elements	All < LOQ	PASS
CRM Recovery (NIST 1577c)	80–120% certified values	97.3%	PASS

1. Test Method & Conditions

Standard:USP <71> Sterility Tests / EP 2.6.1

Method:Membrane Filtration (0.45 μm cellulose nitrate, Millipore HAWP)

Rinse Solution:0.1% Peptone Water (Fluid A per USP), 3 × 100 mL per membrane

Sample Size:56.7 mg dissolved in 10 mL sterile diluent, filtered through 2 membranes

Media:FTM (Fluid Thioglycollate Medium) + SCDM (Soybean-Casein Digest Medium), BD Difco

Environment:ISO Class 5 (Grade A) / ISO Class 7 background, ΔP ≥ 15 Pa

Incubators:Validated Memmert IN110 ± 0.5°C, IQ/OQ/PQ qualified, continuous temperature logging

2. Growth Promotion Test (Media Sensitivity Verification)

Challenge Organism	ATCC No.	Medium	Temp.	Inoculum	Growth	Status
Staphylococcus aureus	ATCC 6538	FTM	32.5°C	< 100 CFU	Turbid < 72h	PASS
Bacillus subtilis	ATCC 6633	FTM	32.5°C	< 100 CFU	Turbid < 72h	PASS
Clostridium sporogenes	ATCC 19404	FTM	32.5°C	< 100 CFU	Turbid < 72h	PASS
Candida albicans	ATCC 10231	SCDM	22.5°C	< 100 CFU	Turbid < 5d	PASS
Aspergillus brasiliensis	ATCC 16404	SCDM	22.5°C	< 100 CFU	Turbid < 5d	PASS

3. Sterility Test Results

Test	Medium	Temp.	Period	Day 7	Day 14	Status
Aerobic Bacteria	FTM (2 tubes)	30–35°C	14 days	Clear	Clear	PASS
Anaerobic Bacteria	FTM (2 tubes)	30–35°C	14 days	Clear	Clear	PASS
Fungi	SCDM (2 tubes)	20–25°C	14 days	Clear	Clear	PASS
Yeasts	SCDM (2 tubes)	20–25°C	14 days	Clear	Clear	PASS
Negative Control	FTM + SCDM	As above	14 days	Clear	Clear	PASS

4. Microbial Enumeration (USP <61> / <62>)

Test Item	Method	Limit	Result	Status
Total Aerobic Microbial Count (TAMC)	Pour plate / TSA / 32.5°C / 5d	≤ 10² CFU/g	< 10 CFU/g	PASS
Total Yeast & Mold Count (TYMC)	Pour plate / SDA / 22.5°C / 5d	≤ 10¹ CFU/g	< 10 CFU/g	PASS
Escherichia coli	Enrichment + MacConkey	Absent / 1 g	Not Detected	PASS
Salmonella spp.	Enrichment + XLD/HE agar	Absent / 10 g	Not Detected	PASS
Staphylococcus aureus	Enrichment + Baird-Parker	Absent / 1 g	Not Detected	PASS
Pseudomonas aeruginosa	Enrichment + Cetrimide	Absent / 1 g	Not Detected	PASS
Bile-Tolerant Gram-Negative (BTGNB)	Enrichment + VRBGA	≤ 10² CFU/g	Not Detected	PASS

1. Test Method & Instrumentation

Standard:USP <85> Bacterial Endotoxins Test / EP 2.6.14

Method:Kinetic Turbidimetric LAL Assay

Instrument:Lonza PyroGene™ rFC Detection System + BioTek ELx808 microplate reader

LAL Reagent:Lonza PYROGENT™ Plus, λ = 0.03 EU/mL (Lot: L4918, Exp: 2026-11)

Reference Std. (RSE):USP Reference Standard Endotoxin (E. coli O55:B5), Potency: 10,000 EU/vial

LAL Reagent Water:Lonza LAL Water, tested < 0.005 EU/mL (Lot: W6312)

Sample Preparation:56.7 mg in 1.0 mL LAL water → vortex 30s → serial dilution to MVD

2. Endotoxin Limit Calculation

Parameter	Value
Maximum Daily Dose (M)	10 mg/kg (assumed max parenteral)
Threshold Pyrogenic Dose (K)	5.0 EU/kg/hr (parenteral, non-intrathecal)
Endotoxin Limit = K/M	0.50 EU/mg
Maximum Valid Dilution (MVD)	1:8
Actual Test Concentration	0.24 mg/mL (diluted to MVD)

3. System Suitability Validation

Validation Item	Acceptance Criteria	Result	Status
Standard Curve \|r\| Correlation	\|r\| ≥ 0.980	0.9972	PASS
Standard Curve Slope	−1.0 ± 0.5 (log-log)	−1.157	PASS
Standard CV (each conc.)	≤ 25%	Max: 13.0%	PASS
Positive Product Control (PPC) Recovery	50–200%	110.3%	PASS
Negative Control	< λ (0.03 EU/mL)	< 0.005 EU/mL	PASS
Interference Test	Recovery 50–200%	103.3%	PASS

4. Standard Curve Data

Conc. (EU/mL)	Reaction Time 1 (s)	Reaction Time 2 (s)	Mean (s)	log(Mean)	CV%
5	214	185	200	2.301	14.5%
0.5	207	222	215	2.332	7.0%
0.05	273	299	286	2.456	9.1%
0.005	1010	990	1000	3.000	2.0%

5. Sample Endotoxin Result

Test Item	Limit	Replicate 1	Replicate 2	Mean	Status
Bacterial Endotoxin (EU/mg)	≤ 0.50	0.109	0.041	0.075	PASS

1. Stability Study Protocol

Guideline:ICH Q1A(R2) Stability Testing, ICH Q1B Photostability

Protocol No.:STAB-CBL60-2026-01

Batch No.:COA-CBL60-2315

Packaging:Amber glass vial, PTFE-lined cap, N₂ backfill, secondary PE bag + desiccant

Accelerated Conditions:40°C ± 2°C / 75% RH ± 5% RH (ICH Zone IVb)

Long-term Conditions:25°C ± 2°C / 60% RH ± 5% RH

Photostability:ICH Option 2: ≥ 1.2 million lux·hours + ≥ 200 W·h/m² near-UV

Parameters Monitored:Appearance, Assay (HPLC), Impurities, Moisture (KF), Sterility

Timepoints:0, 1M, 2M, 3M, 6M (accel.); 0, 3M, 6M, 9M, 12M, 18M, 24M (long-term)

2. Accelerated Stability Data (40°C / 75% RH)

Parameter	Specification	T=0	1 Month	2 Months	3 Months	6 Months
Appearance	White powder	Conforms	Conforms	Conforms	Conforms	Conforms
Assay (%)	95.0 – 105.0	99.1	99.0	98.9	98.8	98.6
Max Single Impurity (%)	≤ 0.50	0.10	0.15	0.14	0.11	0.14
Total Impurities (%)	≤ 2.0	0.9	1.0	1.1	1.2	1.4
Moisture (%)	≤ 1.0	0.30	0.15	0.21	0.32	0.44

3. Long-term Stability Data (25°C / 60% RH)

Parameter	Specification	T=0	3 Months	6 Months	12 Months	24 Months
Appearance	White powder	Conforms	Conforms	Conforms	Conforms	Conforms
Assay (%)	95.0 – 105.0	99.1	99.1	99.0	98.9	98.8
Max Single Impurity (%)	≤ 0.50	0.08	0.09	0.11	0.10	0.11
Moisture (%)	≤ 1.0	0.14	0.26	0.21	0.36	0.35

4. Photostability (ICH Q1B)

Parameter	Before Exposure	After Exposure	Change	Status
Appearance	White lyophilized powder	No significant change	—	PASS
Assay (%)	99.1	99.0	−0.1%	PASS
Degradation Products (%)	0.90	1.00	+0.1%	PASS

Stability Conclusion: This product remains within all specifications under both accelerated conditions (40°C/75% RH) and long-term conditions (25°C/60% RH). Recommended shelf life: 24 months when stored at -20°C, desiccated, protected from light.

GMP

★ P.R. CHINA GMP

Good Manufacturing Practice Certificate

Certificate of GMP Compliance

Cert. No.: CN-GMP-HN-727452-2026

This is to certify that

Hunan Aslsen Technology Co., Ltd.
(Homopeptide)

Address: High-Tech Industrial Development Zone, Changsha, Hunan Province, 410205, P.R. China

Following inspection, the above facility is certified to be in compliance with the Good Manufacturing Practice for Pharmaceutical Products (2010 Revision) for the manufacture of active pharmaceutical ingredients (APIs).

Scope: Active Pharmaceutical Ingredients (Synthetic Peptides, Peptide APIs, Research-Grade Peptides, Chemical Synthesis Intermediates)

Issue Date:2024-03-15

Valid Until:2029-03-14

Audit Body:National Medical Products Administration (NMPA)

Audit Ref.:NMPA-GMP-9385-2024

NMPA

★

GMP Certified

Dr. J. Chen

Lead Auditor, NMPA

Auditor No.: NMPA-AUD-7252

ISO

SGS

QUALITY MANAGEMENT SYSTEM

ISO 9001:2015

Certified by SGS United Kingdom Ltd.

UKAS

Certificate of Registration

Certificate No.: GB24/015217

The management system of

Hunan Aslsen Technology Co., Ltd. (Homopeptide)

has been assessed and certified as meeting the requirements of ISO 9001:2015

for the following scope:

Research, development, manufacture and supply of synthetic peptides, peptide APIs, pharmaceutical raw materials, and research-grade compounds for pharmaceutical and biotech industries.

Initial Certification:2019-06-22

Current Certification:2025-06-22

Expiry Date:2028-06-21

Audit Reference:SGS-QMS-524949

SGS Systems & Services

✦

Certification Body

J. Richardson

General Manager, SGS UK

UKAS Accreditation No. 014

CNAS

CHINA NATIONAL ACCREDITATION SERVICE

ISO/IEC 17025:2017

Laboratory Accreditation Certificate

Accreditation No.: CNAS L12356

Hunan Aslsen Technology Co., Ltd. — Quality Control Center

The above laboratory has been assessed by CNAS and found to comply with the requirements of ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories.

Accredited Fields:
HPLC, GC-FID, GC-MS, ICP-MS, LC-MS/MS, Karl Fischer Titration, Polarimetry, UV-Vis Spectrophotometry, FT-IR, Bacterial Endotoxin Testing (LAL), Sterility Testing, Microbial Limits, Particle Size Analysis (Laser Diffraction), DSC/TGA Thermal Analysis

Accreditation Date:2023-09-01

Valid Until:2027-08-31

CNAS

✦

Accreditation

Dr. L. Wang

CNAS Accreditation Assessor

Assessor No.: CNAS-A5469

Certificate Verification
Scan QR code or visit https://verify.homopeptide.net/COA-CBL60-2315
SHA-256: b99542288ebb6084...
Certificate archived via blockchain — legally binding

Conclusion

All test items of this batch meet the in-house quality specification (HP-QS-CBL60-2026) and comply with USP-NF and EP 11.0 pharmacopoeial requirements. Product quality APPROVED — released for distribution.

APPROVED ✓

Dr. J. Chen

Analyst ID: AN-498 2026-03-17

Dr. L. Wang

Reviewer ID: RV-381 2026-03-17

Dr. M. Zhang

QA Director ID: QA-633 2026-03-17

Quality Control

★

Homopeptide

Hunan Aslsen

★

Technology Co.

cGMP

✓

COMPLIANT

ORIGINAL

DOCUMENT ID: COA-CBL60-2315 | PRINTED: 2026-04-16 | SECURITY CODE: YSIFXQ4F-1Y7K

Cerebrolysin

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