Merck 100366 (S)-Lactic acid about 90%, EMPROVE® EXPERT, Ph. Eur., BP, E 270 2.5 L
Merck 100366 (S)-Lactic acid about 90%, EMPROVE® EXPERT, Ph. Eur., BP, E 270 2.5 L
(S)-Lactic acid about 90%, EMPROVE® EXPERT, Ph. Eur., BP, E 270
(S)-Lactic acid about 90% EMPROVE® EXPERT is a pharmaceutical-grade lactic acid product from the SAFC® portfolio. It is designed for pharmaceutical and biopharmaceutical formulation applications requiring controlled quality and extensive regulatory documentation.
Brand: SAFC / MerckCatalog Number: 100366
Product Number: 1.00366
Product Line: EMPROVE® EXPERT
Grade: Ph. Eur., BP, E 270
Concentration: About 90%
CAS Number: 79-33-4
Empirical Formula: C3H6O3
Molecular Weight: 90.08 g/mol
Form: Liquid
Storage Temperature: 2… 25 °C
KEY FEATURES
- Pharmaceutical-grade (S)-lactic acid
- About 90% concentration
- EMPROVE® EXPERT product line
- Ph. Eur. and BP pharmacopoeial designations
- E 270 identification
- Suitable for pharmaceutical formulation applications
- Applicable to oral, topical and parenteral formulation development
- Manufacturer documentation supporting qualification and regulatory assessments
- Quality specifications including low microbial and endotoxin limits
PROPERTIES
| Property | Specification |
|---|---|
| Brand | SAFC / Merck |
| Catalog Number | 100366 |
| Product Number | 1.00366 |
| Product Name | (S)-Lactic acid about 90%, EMPROVE® EXPERT, Ph. Eur., BP, E 270 |
| Product Line | EMPROVE® EXPERT |
| Quality Segment | 500 |
| Agency | BP, Ph. Eur. |
| Concentration | About 90% |
| Form | Liquid |
| CAS Number | 79-33-4 |
| Empirical Formula | C3H6O3 |
| Molecular Weight | 90.08 g/mol |
| E Number | E 270 |
| MDL Number | MFCD00064266 |
| Beilstein/REAXYS Number | 1720251 |
| UNSPSC | 12352106 |
| Storage Temperature | 2… 25 °C |
TECHNICAL SPECIFICATIONS
| Parameter | Specification |
|---|---|
| Concentration | 90% (approximate) |
| pH | 2.8 (20 °C, 10 g/L in H2O) |
| Density | 1.21 g/cm³ at 20 °C |
| Boiling Point | 122 °C at 20 hPa |
| Melting Point | 18 °C |
| Vapor Pressure | 0.1 hPa at 25 °C |
| Storage Temperature | 2… 25 °C |
Physical properties are taken from the manufacturer's general product information. Lot-specific chemical, microbial and endotoxin results must be checked using the applicable quality documentation.
DESCRIPTION
General Description
Finding the right excipient that matches your needs as well as regulatory demands can be a complicated challenge in formulation. With our application know-how and regulatory expertise, we support you in every step of development, scale-up, and production.
As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.
Application
Lactic acid is used as an acidifying agent in a oral, topical and parenteral formulations.
Due to its low microbial and endotoxin limits, (S)-Lactic acid about 90% Emprove® Expert is especially suitable for high-risk applications.
Legal Information
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany.
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany.
APPLICATION AREAS
- Pharmaceutical formulation
- Biopharmaceutical formulation and manufacturing
- Oral formulation development
- Topical formulation development
- Parenteral formulation development
- Liquid formulations
- Semi-solid formulations
- Acidifying agent applications
- Selected API processing applications, including salt and cocrystal formation
Suitability for any final pharmaceutical dosage form is subject to formulation studies, relevant regulatory requirements and the manufacturer's current quality documentation.
PACKAGING
| Manufacturer SKU | Pack Size |
|---|---|
| 1003662500 | 2.5 L |
| 1003669025 | 25 L |
Packaging options and commercial availability may vary by country. Verify the selected manufacturer SKU before ordering.
SAFETY AND HANDLING
| Safety Information | Classification |
|---|---|
| Signal Word | Danger |
| GHS Pictogram | GHS05 |
| Hazard Statement H314 | Causes severe skin burns and eye damage. |
| Supplemental Hazard EUH071 | Corrosive to the respiratory tract. |
| Hazard Classification | Skin Corr. 1C; Eye Dam. 1 |
| Storage Class | 8A – Combustible corrosive hazardous materials |
| Storage Temperature | 2… 25 °C |
Handling Precautions
Handle using appropriate laboratory ventilation and personal protective equipment. Avoid contact with skin and eyes, and prevent inhalation of mist or vapors. Consult the current Safety Data Sheet for suitable protective gloves, eye and face protection, emergency measures and chemical compatibility information.
Storage
Store in accordance with the manufacturer's specified temperature range of 2… 25 °C. Keep the container closed and protect the product from incompatible materials and conditions that may compromise its quality.
TECHNICAL DOCUMENTS AND CERTIFICATES
▣ PDF Safety Data Sheet (SDS)
Current product safety information and handling requirements.
View Manufacturer Safety Documentation
▣ PDF Certificate of Analysis (CoA) and Certificate of Quality (CoQ)
Lot-specific quality documentation and analytical results.
EMPROVE® EXPERT Documentation
Manufacturer regulatory and quality dossiers supporting excipient qualification and compliance assessments.
View EMPROVE® Product Documentation
Document access and availability may require a manufacturer account. Select the appropriate lot or batch number for specific certificates.
FREQUENTLY ASKED QUESTIONS
What is Merck 100366?
Merck 100366 is (S)-Lactic acid about 90%, EMPROVE® EXPERT, Ph. Eur., BP, E 270, a pharmaceutical-grade lactic acid product from the SAFC® portfolio.
What is the product concentration?
The manufacturer describes the product concentration as about 90%. Exact lot-specific results should be checked using the applicable Certificate of Analysis.
Is this product suitable for pharmaceutical applications?
The product is intended for pharmaceutical formulation applications, including oral, topical and parenteral formulations. Final suitability is determined by process requirements, qualification procedures and applicable regulatory standards.
What is the advantage of EMPROVE® EXPERT?
The EMPROVE® EXPERT product line is supported by extensive quality and regulatory documentation, providing information for material qualification and pharmaceutical manufacturing assessments.
What pack sizes are listed by the manufacturer?
The manufacturer lists 2.5 L and 25 L configurations in its international product catalog. Regional availability should be confirmed before ordering.
How should Merck 100366 be stored?
The manufacturer's specified storage temperature is 2… 25 °C. Follow the current Safety Data Sheet and manufacturer handling instructions.
PRODUCT INFORMATION AND QUOTATION
For availability, packaging options, manufacturer quality documentation, Certificates of Analysis and quotation requests for Merck 100366 (S)-Lactic acid about 90%, EMPROVE® EXPERT, Ph. Eur., BP, E 270, please contact Labor Teknik AŞ.
Website: www.labor.com.tr