Comprehensive Study of a Handheld Raman Spectrometer for the Analysis of Counterfeits of Solid-Dosage Form Medicines

Table 1

Validation results obtained with the genuine products. The number of signatures measured for each product has been added. The minimum values (pVal min) obtained for the validation samples of the corresponding method are presented in the table together with the corresponding maximum values (pVal max) of the closest other products. The device provides a positive identification for values superior or equal to 0.05.

Sample type	Product (%API)	Number of signatures	Validation
			pVal min of; validation samples	pVal max of closest; other products
Tablets	Product 1 (71%)	9	0.1404	0.0000
	Product 2 (36%)	9	0.5973	0.0105
	Product 2 (72%)	9	0.3576	0.0013
	Product 3 (80%, 95%)	18	0.5455	0.0000
	Product 4 (67%, 75%)	12	0.4137	0.0000
	Product 5 (25%, 33%)	18	0.3439	0.0171
	Product 6 (61%)	9	0.4847	0.0000
	Product 7 (57%)	9	0.4490	0.0007
	Product 7 (56%)	9	0.4106	0.0042
	Product 8 (17%)	9	0.4031	0.0083
	Product 9 (3%, 6%, 12%, 30%)	36	0.1292	0.0000
	Product 10 (8%)	9	0.5329	0.0044
	Product 10 (4%)	9	0.4481	0.0010
	Product 11 (3%)	9	0.6458	0.0129
	Product 12 (75%)	9	0.5785	0.0000
	Product 13 (0.4%, 0.8%, 1%, 2%, 3%)	54	0.4089	0.0145
	Product 14 (61%)	9	0.6009	0.0000
	Product 15 (12%)	9	0.4619	0.0167
	Product 16 (51%)	9	0.4299	0.0000
	Product 17 (25%, 45%)	27	0.4416	0.0000
	Product 18 (2%)	9	0.6275	0.0015
	Product 19 (0.3%, 0.6%, 1%)	24	0.1763	0.0009
	Product 20 (24%, 32%)	27	0.3453	0.0000
	Product 21 (75%)	6	0.5781	0.0000
	Product 22 (70%)	9	0.1562	0.0000
	Product 23 (1%, 3%, 6%)	36	0.4444	0.0348
	Product 24 (41%)	9	0.5872	0.0000
	Product 25 (77%, 78%)	18	0.5822	0.0000
	Product 26 (0.8%)	24	0.1807	0.0352
Capsules	Product 27 (83%)	9	0.6223	0.0000
	Product 28 (49%)	9	0.5439	0.0000
	Product 29 (76%)	6	0.5920	0.0000
	Product 30 (49%)	9	0.1669	0.0000
	Product 31 (83%)	18	0.1218	0.0000
	Product 32 (50%)	9	0.1165	0.0000
Powders	Product 33 (81%)	30	0.6139	0.0000