We provide analytical services for NCEs, APIs and formulation of DS and DP. We are well equipped with high-end instruments for purification like Mass Directed Purification (MDD) and Supercritical Fluid Chromatography (SFC). We also facilitate impurity identification, characterization and isolation. We provide end-to-end support for analytical services. The state-of-the-art infrastructure at our R and D centers is well-equipped with the latest analytical instruments that enable us to provide high-quality, cost-effective services for our customers.
Our Custom Services
- Purity of enantiomers
- Identification of related substances and assay
- Prep purification
- Mass directed purification
- Supercritical Fluid Chromatography (SFC)
- Method development for non-chromophoric compounds
- Fate and purge studies
- Genotoxic Impurity (GTI) studies
- Impurity isolation and characterization
- Assay, dissolution, content uniformity and impurities content studies
Analytical Instrumentation
- SFC
- DSC, FT-IR
- HPLC with VWD, DAD, ELSD, CAD and RID
- UPLC with VWD and DAD
- LC-MS/MS triple quard
- LCMS-TOF
- GC and GC-HS
- GC-MS (EI/CI MSD)
- ICP-OES
- NMR 400 MHz
- Amino Acid Analyzer
- UV-VIS Spectrophotometer
- FT-IR Spectrophotometer
- Polarimeter
- Auto-titrator and KF Apparatus
- Differential Scanning Calorimeter
- Thermo Gravimetric Analyzer
Purification
- Reverse phase
- Normal phase
- Chiral
Characterization
- Identification
- Physiochemical
- Structure elucidation
- Impurity profiling or characterization
Analytical Methods
- Analytical method development
- Analytical method validation
- Analytical methoxy transfer
- Analytical method optimization
Impurities
- Genotoxicity impurities
- Nitosin impurities
Stability Studies
- Drug substance
- Impartial stability study
- Whole time stability study
Why Aurigene Pharmaceutical Services?
Hyphenated analytical instruments
Experience in handling complex molecules
Strong data integrity and digitization
End-to-end support for analytics
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Pharmaceutical Analytical Services
Resources
Role of Peptide Synthesis Based Drugs
Amino acids, peptides and proteins play multiple roles in the normal functioning of the body.Group of amino acids between 2 to 50 are called peptides. They often act as hormones and play diverse roles in the normal biological processes in the human body such as metabolism, intercellular signaling and neurotransmission.Peptide synthesis based drug have a high pote...
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Accelerating Drug Discovery Through Innovative Partnerships
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....
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Technology meets sustainability - How a complex API development process goes green
We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more....
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An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives
2016
A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2005
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in tablets
2005
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E) 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
2005
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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Frequently asked questions
What experience does Aurigene have with Pharmaceutical Analytical Services?
- Analytical method development, method validation, and method transfer of Key Starting Materials ( KSM), Intermediates and drug substance. We also have experience in developing and validating following analytical methods.
- Purity/Related substances/Assay by HPLC
- Purity/Related substances/Assay by GC
- Residual solvents by GC/GC-HS
- Impurity profiling by HPLC/GC/LC-MS/GC-MS
- Identification and characterization, quantification of impurities by LC-MS/GC-MS & NMR
- Trace level elemental impurities identification and quantification by ICP-MS
- Genotoxic impurities
- Cleaning method development and validation
- Holding study/stability studies
- Hygroscopic study (EP/USP)
- Melting point determination/identification of different polymorphs/determination of Glass transition temperatures by DSC
- Safety studies for the reaction mass samples by DSC
- Thermogravimetric analysis for the samples (TGA)
- Trace level ions determination by Ion chromatography
- Particles size distribution (PSD)
- Purification/isolation of impurities and characterization
- Purification/isolation of desired compounds
- Amino acids analysis
- Peptide analysis
- CMC activities (establishment of Physico-chemical properties for the regulatory submission)
Which samples can be analyzed at Aurigene?
We can analyze the below development samples related to
- Testing of raw materials
- Testing of in-process samples
- Testing of intermediates
- Testing of drug substance
Which guidelines does Aurigene use to perform method validation?
Below are the set of guidelines used for method validation
| <1225>&<1226> | US Pharmacopoeia chapter |
| CDER Guidance | Guideline for Submitting Samples and Analytical Data for Methods Validation. February 1987. |
| CDER Reviewer Guidance | Validation of Chromatographic methods. November 19 |
| ICH Q2 (R1) | Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization |
| ICH Q6A | Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, International Conference on Harmonization. |
| ICH Q7 | GMP Guidance for Active Pharmaceutical Ingredients, International Conference on Harmonization. |
| RDC.N°17 | Good Practices for medicament manufacturing |
| RDC.N°53 | “Establishes parameters for reporting, identification and qualification of degradation products in synthetic drugs with active substances and semi-synthetic classified as new, generic and the like and other measures”. |
| RE.N°166 | Guide for validation of Analytical and Bio-analytical methods |
| USP General chapters | General tests and assays. |
Which analytical lab equipments or instruments are used at Aurigene?
Below is the list of equipments or instruments used
- HPLCs with wide range of detectors (UV, PDA, CAD, RID and ELSD), Waters and Agilent
- GC with Headspace and FID, Agilent make
- GC-MS Agilent make (model: 5975C)
- LC-MS- AB Sciex QTRAP 4500
- UPLC-TOF, Waters
- ICP-MS- Agilent make (model: 7800)
- Ion chromatography, Metrohm
- FT-IR, spectrum one, Perkin Elmer make (model: spectrum one)
- Polarimeter, Jasco (model P2000)
- Karl-Fisher apparatus, Metrohm
- Auto titrator, Metrohm
- Differential scanning calorimeter (DSC), TA (model: TA DSC Q 2000)
- Thermo gravimetric analyzer (TGA), TA
- Particle size analyzer, Master sizer 3000
- Amino acid analyzer, Sykam
Does Aurigene perform analytical method development in order to ensure that the analytical method is 'stability-indicating'?
Stability indicating nature of analytical method will be demonstrated during analytical method development of drug substance related substances and assay method. To demonstrate the stability indicating nature of analytical method, degradation samples shall be generated by stressing the test sample with acid, base, water hydrolysis, oxidative, thermal and photostability study. The degraded sample shall be analyzed and demonstrated the separation of degradation impurities from known impurities and analyte peak. Photostability study shall be carried out as per ICH QIB.
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