How to Choose a Refractometer: Pharmaceutical Industry

Pharmaceutical and Toxicology Testing

  • Total Parenteral Nutrition (TPN)
  • Toxicology Testing (Urine SG)
  • Pharmacy compounding and drug diversion
  • USP <831>
  • EP 2.2.6
  • Enflurane
  • Sevoflurane

Feature Highlight

Pharmaceutical Industry Feature Highlight

Enflurane, Sevoflurane and similar halogenated ethers are used extensively for the induction and maintenance of general anesthesia. Their manufacture must comply with specifications from the USP/EP or relevant pharmacopeias. Many of these pharmacopeias require the measurement of refractive index. For example, the US Pharmacopeia requires that sevoflurane has a refractive index of 1.2745 - 1.2760 at 20°C. For 21CFR Part 11 compliance choose MMC option.

Pharmaceutical Models Specification Features and Benefits
J257-CC Measurement Range: 1.26 - 1.70 RI; 0 - 95% Brix
Accuracy: 0.0001 RI; 0.1 Brix
Electronic Temperature Control: Flexible temperature selection between 15°C - 70°C

USP General Subchapter <831> Refractive Index States:
…Although the standard temperature for Pharmacopeial measurements is 25°C, many of the refractive index specifications in the individual monographs call for determining this value at 20°C. The temperature should be carefully adjusted and maintained, since the refractive index varies with the temperature…
…To achieve the theoretical accuracy of ±0.0001, it is necessary to calibrate the instrument against a standard provided by the manufacturer and to check frequently the temperature control and cleanliness of the instrument by determining the refractive index of distilled water, which is 1.3330 at 20°C and 1.3325 at 25°C…
The J357-MMC-CC provides the refractive index range, accuracy, performance and 21CFR Part 11 compliance demanded by big pharma making this our most popular pharmaceutical model.

J357MMC-CC Measurement Range: 1.26 - 1.70 RI; 0 - 95% Brix
Accuracy: 0.00004 RI; 0.03 Brix
Electronic Temperature Control: Flexible temperature selection between 15°C - 100°C
Medical Testing and Toxicology Models Specification Features and Benefits
J57HA Measurement Range: 1.33 - 1.53 RI; 0 - 95% Brix, 1.000 - 1.0500 Urine SG
Accuracy: 0.0002 Urine SG; 0.00004 RI; 0.03 Brix
Electronic Temperature Control: Fixed temperature selection: 20°C and 25°C 		The J-Series Refractometer is chosen by more toxicology labs than any other brand. These customers know that 0.0002 Urine SG accuracy must be validated regularly and Rudolph’s J57 ensures that the refractive index performance and calibration requirements meet government regulations. The J57HA’s standard sample volume is 500 micro liters but this can be reduced to 100 micro liters by selecting the J57HA-SV.
J57HA-UF-SP Measurement Range: 1.33 - 1.53 RI; 0 - 95% Brix, 1.000 - 1.0500 Urine SG
Accuracy: 0.0002 Urine SG; 0.00004 RI; 0.03 Brix
Electronic Temperature Control: Fixed temperature selection: 20°C and 25°C 		SAMSHA labs doing hundreds of toxicology samples per day prefer to eliminate the human factor and choose large scale automation. The J57HA-UF-SP is combined with a custom automation solution that minimizes sample use and replaces the tested sample to the testing vial.
J57TPN Measurement Range: 1.33 - 1.53 RI; 0 - 95% Brix, 1.000 - 1.0500 Urine SG
Accuracy: 0.0002 Urine SG; 0.00004 RI; 0.03 Brix
Electronic Temperature Control: Fixed temperature selection: 20°C and 25°C 		For large hospitals doing their own pharmaceutical compounding, ensuring that their Total Parenteral Nutrition formulas are accurate is life critical. The J57TPN was specifically customized to meet USP<797>. Please contact the factory for the white paper on this application.