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Updated: Jan 7, 2026
Genotyping of Staphylococcus aureus by Ribosomal Spacer PCR RS-PCR
Published on: November 4, 2016
Molecular phylogenetic and biochemical characterization of Staphylococcus aureus isolates from non-sterile
Kajal Sharma1, Sonika Bakshi1, Paruv Sachdeva1
1Department of Allied Health Sciences, Chitkara School of Health Sciences, Chitkara University, Rajpura, Punjab, 140401, India.
Background:
Contamination of cough syrups not produced under sterile conditions is dangerous for users and can affect product quality.
Methods:
The bacterial quality was investigated in 15 cough syrup samples collected from Punjab, India (validity: January-June 2024). This was confirmed when contamination was measured via membrane filtration (0.45 μm pores) and microbes were grown on Tryptone Soya Agar, mannitol salt agar, Xylose Lysine Deoxycholate Agar and Eosin Methylene Blue Agar. The number of isolates (CFU/mL) was determined, and the isolates were identified using Gram staining, biochemical tests, and 16S-rRNA gene sequencing.
Results:
The presence of genetic variation among organisms was also evaluated. Only one out of 15 samples (6.66%) had levels higher than allowed, three others (20%) were near the limit, and the rest (73.33%) were below the United States Pharmacopeia (USP) limit ( 10³ CFU/mL) for bacterial contamination. Staphylococci sp. were present in syrups C, D, L, and O according to biochemical testing. The results for syrup C showed that Staphylococcus aureus (GenBank: PV137763) was above the level required by the USP. Genetic diversity analysis revealed six main haplotypes, with a high haplotype diversity (Hd= 0.8667) and nucleotide diversity (Pi = 0.09097), suggesting that the population is either expanding or undergoing purifying selection.
Conclusion:
The majority of syrups were of good quality; however, there were contaminated samples, which raised doubts about how they were produced. It is recommended that good manufacturing practices be strictly enforced. Larger and ongoing quality control studies should be conducted to evaluate product safety.
Insights
Bacterial contamination in cough syrups can pose risks. While most samples met quality standards, some showed concerning levels, highlighting the need for strict manufacturing practices and ongoing quality control to ensure product safety.
Area of Science:
- Microbiology
- Pharmaceutical Quality Control
- Bacterial Genetics
Background:
- Non-sterile cough syrup production poses risks to users and product integrity.
- Bacterial contamination is a significant concern in pharmaceutical preparations.
- Ensuring the microbial quality of oral liquid medications is crucial for public health.
Purpose of the Study:
- To assess the bacterial quality of cough syrup samples from Punjab, India.
- To identify and quantify microbial contaminants in pharmaceutical syrups.
- To evaluate compliance with established pharmacopeial standards for bacterial load.
Main Methods:
- Collected 15 cough syrup samples for analysis between January and June 2024.
- Employed membrane filtration (0.45 μm) and diverse agar media for microbial isolation.
- Utilized Gram staining, biochemical tests, and 16S-rRNA gene sequencing for isolate identification.
Main Results:
- 73.33% of samples were below the United States Pharmacopeia (USP) limit (<10³ CFU/mL).
- One sample (6.66%) exceeded the USP limit, and three (20%) were near the limit.
- Staphylococcus aureus was identified in one syrup exceeding USP standards; high haplotype and nucleotide diversity were observed.
Conclusions:
- The majority of cough syrups demonstrated acceptable microbial quality.
- Contaminated samples indicate potential issues in manufacturing processes.
- Strict adherence to Good Manufacturing Practices (GMP) and continuous quality monitoring are recommended.
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